Northfield, IL, United States
MEDLINE INDUSTRIES, LP - Northfield recalls
120 recalls recorded since 2018, most recently on 25 July 2025. 107 are listed as ongoing. Status and classification are as published by the FDA.
Recalls120
Ongoing (FDA)107
Terminated or completed13
Class I (FDA)12
Ongoing Class I Medical devices
- Recall started
- 25 July 2025
- Reason
- Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
- Distribution
- US distribution to: AL, CA, DE, OR, TN, TX
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2566-2025, Z-2567-2025
- Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION TRAY, Kit Number ACC010379A; 3. INTUBATION TRAY, Kit Number ACC010392; 4. INTUBATION KIT, Kit
- Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C; 2. DRAWER 5 - POSITION 3, Kit Number ACC010532; 3. DRAWER #4C ADULT, Kit Number ACC010671; 4. DRAWER #2, Kit Numb
Ongoing Class II Medical devices
- Recall started
- 23 July 2025
- Reason
- Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patient risk ranges from minor injury to injury that requires medical intervention, such as infection or local/systemic allergic reaction (anaphylaxis).
- Distribution
- Domestic distribution to FL and IL. No OUS distribution reported.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2479-2025
- Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTOMY DYNJ908819B KIT CRANIOTOMY (only units from SKU DYNJG001004A LAV
Ongoing Class I Medical devices
- Recall started
- 14 July 2025
- Reason
- Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2460-2025
- Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH
Ongoing Class II Medical devices
- Recall started
- 8 July 2025
- Reason
- Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange may detach from the bladder at the welded connection point. This detachment compromises the cuff's ability to maintain adequate air pressure, potentially resulting in tourniquet failure and increased risk of patient hemorrhaging.
- Distribution
- US Nationwide distribution tin the states of CA, FL, IA, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2452-2025
- The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of components dependent upon
Ongoing Class II Drugs
- Recall started
- 7 July 2025
- Reason
- Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0604-2025, D-0601-2025, D-0602-2025, D-0600-2025, D-0605-2025, D-0603-2025
- Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 19428, Made in China: 100 eaches per box, 30 boxes per case, (3,000 eaches per case), NDC 46122-043-78.
- CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www
- ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart, Inc., Bentonville, AR 72716 Walmart: 200 eaches per box, 24 boxes per case (4,800 eaches per case), NDC 49035-814-60.
- Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC
- RITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200 NEWBERRY COMMONS, ETTERS, PA 17319, NDC 11822-5156-2.
- H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PARA H-E-B, San Antonio, TX 78204, NDC 37808-809-09.
Ongoing Class II Medical devices
- Recall started
- 16 June 2025
- Reason
- SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection/sepsis.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Panama.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2199-2025
- SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
Ongoing Class II Medical devices
- Recall started
- 12 June 2025
- Reason
- Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
- Distribution
- Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2155-2025, Z-2154-2025, Z-2156-2025, Z-2153-2025
- Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOOD CULTURE KIT, REF DYNDH1622C; 3) BLOOD CULTR KT DIVRSN DEVICE, REF DYNDH1866.
- Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P
- Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
- Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
Ongoing Class II Medical devices
- Recall started
- 23 May 2025
- Reason
- Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
- Distribution
- US Nationwide distribution in the states of IN, KY, CA, MI, TX, WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2043-2025, Z-2044-2025, Z-2045-2025
- Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY
- Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
- Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B
Ongoing Class II Medical devices
- Recall started
- 15 May 2025
- Reason
- There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
- Distribution
- US Nationwide distribution in the state of VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1995-2025
- Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Ongoing Class I Medical devices
- Recall started
- 22 April 2025
- Reason
- Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
- Distribution
- US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1809-2025, Z-1810-2025, Z-1811-2025
- Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS, SKU CDS983467J 4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927 5. MAJO
- Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
- Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PACK-LF SKU DYNJ44805M 3. CRANIOTOMY SKU CDS982719V CDS982719W DYNJ904168F DYNJ908404B DYNJ90
Ongoing Class II Medical devices
- Recall started
- 9 April 2025
- Reason
- Three is the potential for the retractors to puncture through the sterile packaging.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1766-2025, Z-1765-2025
- Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
- Centurion Sterile Weitlaner Retractor, Reorder: 67315
Ongoing Class II Medical devices
- Recall started
- 24 March 2025
- Reason
- A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1719-2025
- Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
Ongoing Class II Medical devices
- Recall started
- 19 March 2025
- Reason
- It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1707-2025, Z-1709-2025, Z-1706-2025, Z-1705-2025, Z-1712-2025, Z-1713-2025, Z-1710-2025, Z-1711-2025, Z-1708-2025, Z-1714-2025
- Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
- Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF DYNDC1311C; 4) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185; 5) NURSING
- Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
- Medline Sterile Water, USP, 100mL, REF RDI30295
- Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
- Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
- Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
- Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.
- and 2 more product lines
Ongoing Class II Medical devices
- Recall started
- 5 March 2025
- Reason
- Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
- Distribution
- US Nationwide distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1548-2025, Z-1547-2025, Z-1546-2025, Z-1549-2025
- MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R
- MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R
- MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable, Item Number REF EICA58720R
- MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R
Ongoing Class II Medical devices
- Recall started
- 3 March 2025
- Reason
- There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1605-2025, Z-1614-2025, Z-1618-2025, Z-1612-2025, Z-1599-2025, Z-1587-2025, Z-1611-2025, Z-1595-2025, Z-1601-2025, Z-1613-2025, Z-1610-2025, Z-1606-2025 and 22 more
- Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;
- Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A; 2) C-SECTION PCH-LF, Model Number: DYNJ81281; 3) C-SECTION PACK-LF, Model Number: OBK387M; 4) C-SECTION PC
- Refer to RES
- Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B
- Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH FOL UM MF 10ML, Model Number: DYND150200S
- Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A
- Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ0378319P; 3) VUWC OB PACK, Model Number: DYNJ64017B; 4)
- Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Model Number: DYNJ56229A; 3) DENTAL PACK-LF, Model Number: PHS807626F; 4) DENTAL PACK SMGH, Model N
- and 26 more product lines
Ongoing Class I Medical devices
- Recall started
- 24 February 2025
- Reason
- Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.
- Distribution
- California
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1505-2025
- Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION KIT, REF ACC010381A; 3) NEWBORN RESUSCITATION KIT, REF ACC010381B; 4) NEWBORN RESUSCITATION KIT,
Ongoing Class I Medical devices
- Recall started
- 21 February 2025
- Reason
- Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.
- Distribution
- US: CA, FL, MN, NY, OH, OR, PA, TX, WV
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1457-2025, Z-1459-2025, Z-1456-2025, Z-1458-2025
- Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
- Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, TOL DR. M PACK.
- Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PAR
- Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF
Ongoing Class II Medical devices
- Recall started
- 19 February 2025
- Reason
- There is a potential for the sterility of the device to be compromised.
- Distribution
- Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Bermuda, Canada, Panama, Singapore
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1531-2025, Z-1530-2025
- Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE HYDROCOLLOID ALL PURP 10CT, Model Number: MJ18005V2; 3) MJ BNDG HYDROCOLLOID FINGER TOE 8CT, Model Number:
- Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93", 2) Model Number: MJ18004, DBD-MEIJER,BANDAGE,HYDROCOLLOID,HEEL,OVL 3) Model Number: MJ18005, MEIJER,BANDAGE,HYDROCOLLOID,A
Ongoing Class II Drugs
- Recall started
- 17 February 2025
- Reason
- Subpotent Drug
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0289-2025, D-0288-2025
- CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www
- Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC
Ongoing Class II Medical devices
- Recall started
- 13 February 2025
- Reason
- Potential breach in pouch packaging which could lead to loss of sterility.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1364-2025, Z-1370-2025, Z-1369-2025, Z-1368-2025, Z-1366-2025, Z-1365-2025, Z-1363-2025, Z-1367-2025
- Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK
- Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.
- Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
- Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surgical drape.
- Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
- Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
- Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST
- Proxima Drape labeled as FACE LIFT. Sterile surgical drape.
Ongoing Class II Medical devices
- Recall started
- 12 February 2025
- Reason
- The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
- Distribution
- Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1431-2025, Z-1428-2025, Z-1430-2025, Z-1429-2025
- namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *, REF 60010511; 3) MTS,LT,HT,KIT-BRYAN,LGH,M.C.,EAST, REF 60020323; 4) MTO,RIGHT,KIT-BRO
- namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
- namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710
- namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160
Ongoing Class II Medical devices
- Recall started
- 11 February 2025
- Reason
- Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1453-2025, Z-1439-2025, Z-1445-2025, Z-1441-2025, Z-1443-2025, Z-1435-2025, Z-1438-2025, Z-1447-2025, Z-1446-2025, Z-1452-2025, Z-1451-2025, Z-1449-2025 and 7 more
- Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE KIT, Pack Number 613034702
- Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNEE, Pack Number DYNJ56717A; 3) CVL INSERTION PACK, Pack Number CVI5065; 4) KT DR VELASCO FISTULA
- Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B
- Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSCOPIC GB PACK, Pack Number DYNJ67756A; 3) CHRISTUS WH LAP CHOLE PACK, Pack Number DYNJ60934B 4) CRMC LAP CHOLE DIAG LAP-L
- Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356
- Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2) PAIN MANAGEMENT TRAY-LF, Pack Number DYNJRA1749
- Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J; 3) CABG, Pack Number DYNJ906462B; 4) CABG ACCESSORY PACK-LF, Pack Number DYNJ0261346
- Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D; 2) CSMC/GYN LAPAROSCOPIC PACK-LF, Pack Number DYNJ0665103I; 3) DAVINCI PACK-RFD, Pack Number DYNJ47762O; 4) DAVINCI ROBOT PACK SLR
- and 11 more product lines
Ongoing Class II Medical devices
- Recall started
- 11 February 2025
- Reason
- Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1463-2025, Z-1464-2025, Z-1461-2025, Z-1465-2025, Z-1462-2025
- Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS
- Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B; 2) ANGIOGRAPHY PACK, Pack Number DYNJ21519W; 3) NEURO ANGIO PACK, Pack Number DYNJ83941; 4) NEURO ANGIO PACK SJF-LF, Pack N
- Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; 2) BLEPH/RHINO PACK, Pack Number DYNJ64669A; 3) DB ENT CSTM PACK-LF, Pack Number DYNJ33585C; 4) DENTAL PACK, Pack Numb
- Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number DYNJ64332; 3) ARTHRO PACK-LF, Pack Number DYNJ38748F; 4) ARTHRO PACK-LF, Pack Number DYNJ38748F;
- Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C; 3) CHEST BREAST -LF, Pack Number DYNJCEN04C; 4) DIEP PACK, Pack Number DYNJ60669G;
Ongoing Class II Medical devices
- Recall started
- 11 February 2025
- Reason
- Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
- Distribution
- Worldwide - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1394-2025, Z-1393-2025
- Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC
- Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098
Ongoing Class II Medical devices
- Recall started
- 6 February 2025
- Reason
- Devices may have higher than expected amounts of bacterial endotoxin.
- Distribution
- US Nationwide distribution in the states of AR, AZ, CA, CO, IA, IL, KS, OR, TN, TX, WA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1460-2025
- Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
Ongoing Class II Medical devices
- Recall started
- 9 January 2025
- Reason
- Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.
- Distribution
- US States: CA, NY
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1182-2025, Z-1183-2025
- Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A; 2) ADULT MAIN DISP. INTUB PART A, Model Number DYNJAA262A
- Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBATION DRAWER #2, Model Number ACC010813
Ongoing Class II Medical devices
- Recall started
- 3 January 2025
- Reason
- Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potential sterility issue detected during testing.
- Distribution
- US: CA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1173-2025
- Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
Ongoing Class I Medical devices
- Recall started
- 31 December 2024
- Reason
- The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0992-2025, Z-0991-2025
- Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
- Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item Number ART255; 3) ARTERIAL LINE TRAY, Item Number ART350; 4) ARTERIAL LINE BUNDLE, Item Number
Ongoing Class II Medical devices
- Recall started
- 23 December 2024
- Reason
- Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
- Distribution
- US: FL, KS, ND, PA, WA, WV, IL, WA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1049-2025, Z-1048-2025
- MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.
- CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.
Ongoing Class I Medical devices
- Recall started
- 16 December 2024
- Reason
- Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0765-2025, Z-0764-2025
- Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,ANGIO,DOUBLE,SPIKE,KIT,KENNEDY HLTH, Item Number: 65111341; 3) MTO,ANGIO,SINGLE,SPIKE,KIT, Item Num
- Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222; 3) FDS,135,NV,MICRO-CHAMBER,W/FILTER,GREEN, Ite
Ongoing Class II Medical devices
- Recall started
- 21 November 2024
- Reason
- Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
- Distribution
- Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0778-2025, Z-0792-2025, Z-0793-2025, Z-0790-2025, Z-0791-2025, Z-0779-2025, Z-0777-2025, Z-0786-2025, Z-0789-2025, Z-0781-2025, Z-0787-2025, Z-0784-2025 and 6 more
- Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA PACK, REFDYNJ54242B; 4) OPEN HEART A&B, REFDYNJ901203C; 5) OPEN HEART A&B, REFDY
- Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DYNJ55555D; 3) KIT,SPINE LH, REF DYNJ906448A.
- Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM-LF, REF DYNJ35184F; 3) ANTERIOR CERVICAL-CORPECTOMY, REF DYNJ904827.
- See DocMan
- Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF
- Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF, REF DYNJ0713177; 3) BURR HOLE SHUNT PACK, REF DYNJ56819D; 4) BURR HOLE SHUNT PACK, REF DYNJ5681
- Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIRMING SURGERY, REF DYNJ66252; 4) GENDER AFFIRMING SURGERY, REF DYNJ66252A; 5) MA
- Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-LF, REF DYNJ42833A; 3) FREE FLAP PACK-LF, REF DYNJ42833B; 4) TYMPANOPLASTY PACK, REF DYNJ50692C;
- and 10 more product lines
Ongoing Class II Medical devices
- Recall started
- 18 November 2024
- Reason
- Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
- Distribution
- US and Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0697-2025, Z-0698-2025, Z-0696-2025, Z-0695-2025
- HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device
- HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
- HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device
- HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
Ongoing Class II Medical devices
- Recall started
- 18 November 2024
- Reason
- Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1042-2025, Z-1040-2025, Z-1041-2025
- Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray
- Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray
- Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray
Ongoing Class II Medical devices
- Recall started
- 12 November 2024
- Reason
- Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0758-2025, Z-0756-2025, Z-0757-2025, Z-0755-2025, Z-0760-2025, Z-0754-2025, Z-0759-2025
- ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
- ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870
- STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790
- O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000
- RUMMELL, Medline Item No. ST006ST
- STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695
- ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785
Ongoing Class II Medical devices
- Recall started
- 6 November 2024
- Reason
- Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
- Distribution
- US Nationwide. Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0725-2025, Z-0722-2025, Z-0723-2025, Z-0719-2025, Z-0718-2025, Z-0721-2025, Z-0720-2025, Z-0726-2025, Z-0717-2025, Z-0724-2025
- KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
- SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.
- Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU DYNJ21927Q; 3) MVFF/FIBU #54-RF, SKU DYNJ21927S; 3) NEURO PEDIATRIC, SKU DYNJ61607A; 4) CRANIOTOMY PA
- DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.
- FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..
- Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A
- Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU DYNJ33520A; 4) SINUS PACK, SKU DYNJ44845G; 5) SINUS PACK, SKU DYNJ48330B
- Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N; 2) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119U; 3) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119V; 4) CRANIOTOMY CDS,
- and 2 more product lines
Ongoing Class II Medical devices
- Recall started
- 25 October 2024
- Reason
- Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.
- Distribution
- US Nationwide distribution in the state of NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0558-2025
- ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555
Ongoing Class II Medical devices
- Recall started
- 23 October 2024
- Reason
- Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
- Distribution
- US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0355-2025, Z-0359-2025, Z-0354-2025, Z-0356-2025, Z-0358-2025, Z-0360-2025, Z-0361-2025, Z-0357-2025
- Lab Kit, SKU DYLAB1018; Component No. 503581
- URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581
- Clean Catch Kit, SKU DYKM1833A; Component No. 503581
- UA KIT, SKU DYKM1690A; Component No. 503581
- URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581
- URINE KIT, SKU DYKM1845; Component No. 503581
- URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581
- URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581
Ongoing Class II Medical devices
- Recall started
- 21 October 2024
- Reason
- Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.
- Distribution
- US Nationwide distributions in the states of AL, AR, CO, CT, FL, IA, IN, KS, LA, MA, MO, NC, NY, OK, OR, RI, TN, TX, VA, WA, WY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0465-2025
- Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)
Ongoing Class II Medical devices
- Recall started
- 16 October 2024
- Reason
- The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
- Distribution
- US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0513-2025, Z-0510-2025, Z-0511-2025, Z-0509-2025, Z-0512-2025, Z-0515-2025, Z-0514-2025, Z-0508-2025
- MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY CON EPID 20G NYL W/TUOHY, REF PAIN9023; 4) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281 5) T
- MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20
- MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF PAIN1622A
- MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268C; 3) FEMORAL BLOCK TRAY, REF DYNJRA1739A; 4) FEMORAL BLOCK TRAY, REF D
- MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF PAIN1423A; 2) CONT. 20G EPI MRI COMPATIBLE, REF PAIN1470A; 3) EPIDURAL CATHETERIZATION KIT, REF PAIN1644
- MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699; 2) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699A
- MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT, REF PAIN1876A
- MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Connector
Ongoing Class II Medical devices
- Recall started
- 15 October 2024
- Reason
- Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
- Distribution
- US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0533-2025, Z-0532-2025, Z-0534-2025
- (1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.
- (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.
- Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.
Ongoing Class II Medical devices
- Recall started
- 9 October 2024
- Reason
- Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0632-2025, Z-0623-2025, Z-0624-2025, Z-0639-2025, Z-0645-2025, Z-0636-2025, Z-0625-2025, Z-0640-2025, Z-0637-2025, Z-0634-2025, Z-0643-2025, Z-0644-2025 and 16 more
- MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
- MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2) LOCAL BASIC, REF DYNJ34418L; 3) LOCAL BASIC, REF DYNJ34418M; 4) MINI LOCAL, REF DYNJ900287D
- MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3) PLASTIC PACK, REFDYNJ58409C; 4) GENDER AFFIRMING SURGERY, REFDYNJ66252A; 5) ST CHARLES PORT, R
- MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672
- MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W; 3) C-SECTION, REF CDS980774M; 4) C-SECTION KIT, REF CDS981322AB; 5) C-SECTION KIT, REF CDS981322A
- MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B
- MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, REF CDS840233I; 3) GENERAL AAA #11-RF, REF CDS840261AB; 4) HEART CDS, REF CDS840387T; 5) OPEN HEART CDS PART A, REF CDS840402AF;
- MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780202R; 4) ACDF CDS, REF CDS941061M; 5) NEURO KIT, REF CDS981327Q;
- and 20 more product lines
Ongoing Class II Medical devices
- Recall started
- 4 October 2024
- Reason
- Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.
- Distribution
- US Nationwide distribution in the state of TN.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0349-2025, Z-0350-2025
- CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
- ARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004C
Ongoing Class II Medical devices
- Recall started
- 4 September 2024
- Reason
- It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0175-2025, Z-0165-2025, Z-0164-2025, Z-0167-2025, Z-0159-2025, Z-0156-2025, Z-0151-2025, Z-0180-2025, Z-0172-2025, Z-0179-2025, Z-0178-2025, Z-0153-2025 and 21 more
- Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B; c) GYN ANCILARY PACK, REF DYNJ84509; d) GYN LITHOTOMY MINOR, REF D
- Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c) BREAST PK TEGH-LF, REF DYNJ46717A; d) BREAST PK TEGH-LF, REF DYNJ46717A; e) BR
- Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b) TRAY FOL LATX UM COUD 16FR MF, REF DYND150216CS; c) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150
- Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit
- Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit
- Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT, REF DYNDC2486A; a) OPEN HEART PACK, REF DYNJ01201L; a) BREAST/CHEST SHEET PACK
- Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit
- Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
- and 25 more product lines
Ongoing Class II Medical devices
- Recall started
- 3 September 2024
- Reason
- Product has been identified as having holes in the packaging.
- Distribution
- Worldwide distribution - US Nationwide and the countries of India and Panama.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0133-2025
- (1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Sterile; (3) Centurion CirClamp with 1.13cm Bell and Insert, Reorder #230CR, Sterile; (4) Centurion Ci
Ongoing Class II Medical devices
- Recall started
- 30 August 2024
- Reason
- It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the touch.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama and Jamaica.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0034-2025, Z-0033-2025, Z-0032-2025
- MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
- MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
- MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Ongoing Class II Medical devices
- Recall started
- 28 August 2024
- Reason
- Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0123-2025, Z-0122-2025, Z-0121-2025, Z-0119-2025, Z-0120-2025, Z-0124-2025
- MEDLINE KIT CV I II, REF DYNJ906071B
- MEDLINE OPEN HEART, REF DYNJ904261B
- MEDLINE OPEN HEART PACK, REF DYNJ66216C
- MEDLINE HEART CABG CDS, REF CDS983376R
- MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J
- MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840
Ongoing Class II Medical devices
- Recall started
- 28 August 2024
- Reason
- CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. The Detachable Endo Pocket is indicated for use as a receptacle for the collection and extraction of tissues, organs, and calculi during general and laparoscopic procedures. The tube inside the pouch, which detaches during the removal process, may stretch out from the pouch opening if it is not precisely fixed during the production process. Medline has identified that this product is utilized as a component within the Medline-branded convenience kits.
- Distribution
- US Nationwide distribution in the state of CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0053-2025
- Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
Ongoing Class II Medical devices
- Recall started
- 27 June 2024
- Reason
- XXX
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3120-2024, Z-3118-2024, Z-3106-2024, Z-3119-2024, Z-3111-2024, Z-3110-2024, Z-3114-2024, Z-3109-2024, Z-3115-2024, Z-3107-2024, Z-3105-2024, Z-3121-2024 and 5 more
- Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ59921B; b) AMB VITRECTOMY, Pack Number DYNJ59921BH; c) AMB OCULOPLASTICS MUSC, Pack Number DYNJ5
- Medline convenience kits containing semi-rigid suction liners labeled as follows: MTHZ GYN LAPAROSCOPY, Pack Number DYNJ909739
- Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA0311C; b) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA0323C; c) ANESTHESIA CIRCUIT ADULT, Pa
- Medline convenience kits containing semi-rigid suction liners labeled as follows: MERCY TIFFIN C-SECTION, Pack Number DYNJ909732
- Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO BRONCH PACK, Pack Number DYKE1355; b) ENDO BASIC KIT, Pack Number DYKE1356; c) ENDOSCOPY KIT, Pack Number DYKE1771C
- Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR PROCEDURE, Pack Number CDS981509C; b) GENERAL LAPAROSCOPY CDS, Pack Number CDS981512J; c) OR MAJOR CDS, Pack Number CDS98151
- Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1092B; b) VIDEO BRONCHOSCOPY TRAY, Pack Number DYKE1666; c) SUCTION CANISTER KIT, Pack Number DYKM2196;
- Medline convenience kits containing semi-rigid suction liners labeled as follows: a) BAPTIST FLOYD BRONCHOSCOPY, Pack Number DYKE1456D; b) ENT MINOR, Pack Number DYNJ908099B; c) HEAD & NECK, Pack Number DYNJ908101B;
- and 9 more product lines
Ongoing Class II Medical devices
- Recall started
- 18 June 2024
- Reason
- A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
- Distribution
- US: TX, IL, CA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3069-2024, Z-3072-2024, Z-3070-2024, Z-3071-2024
- CRANIOTOMY PACK, Pack Number DYNJ46552O
- ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A
- KIT PEDI CRANI LAMI, Pack Number DYNJ907372A
- ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377
Ongoing Class II Medical devices
- Recall started
- 7 May 2024
- Reason
- Potential for an incomplete seal on the packaging tray.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3093-2024, Z-3092-2024, Z-3094-2024, Z-3095-2024
- Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1937CR.
- Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR.
- Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF4418CR.
- Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R.
Ongoing Class II Medical devices
- Recall started
- 30 April 2024
- Reason
- There is the potential of the tip protector to fall off 4.5" sterile, curved, Iris Scissors
- Distribution
- Worldwide distribution - US Nationwide and the countries of Singapore, Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2024-2024
- MEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case) and DYNJ04049H (individual unit)
Ongoing Class II Medical devices
- Recall started
- 22 April 2024
- Reason
- It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama, UAE, USVI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1938-2024, Z-1937-2024
- MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020
- MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010
Ongoing Class II Medical devices
- Recall started
- 17 April 2024
- Reason
- These syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified that may pose a risk to patient health.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1936-2024
- Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE L/L LOW PR, Item Number: DYNJSYRPP20B; c) SYRINGE 20ML RED L/L LOW PRESS, Item Number: DYNJSYR
Ongoing Class II Medical devices
- Recall started
- 8 April 2024
- Reason
- Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2754-2024, Z-2739-2024, Z-2752-2024, Z-2743-2024, Z-2741-2024, Z-2744-2024, Z-2747-2024, Z-2759-2024, Z-2764-2024, Z-2765-2024, Z-2755-2024, Z-2756-2024 and 15 more
- Medline procedural kits labeled as: ARTHROGRAPH TRAY, Pack Number MNS12670A
- Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327F; 2) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327G
- Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS12670A; 3) CIRCUMCISION TRAY, Pack Number CIT6860A; 4) CIRCUMCISION TRAY, Pack Number CIT6715;
- Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050Q; 2) OPEN HEART CDS, Pack Number CDS982411N; 3) OPEN HEART, Pack Number CDS983348AA; 4) OPEN HEART, Pack Number CDS983348X; 5) OPEN
- Medline procedural kits labeled as: PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040H
- Medline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920
- Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2) MAJOR EAR , Pack Number CDS982016T; 3) MAJOR EAR PACK, Pack Number CMPJ01846O; 4) EAR PACK, Pack Number CMPJ05884J; 5) MZ EAR P
- Medline procedural kits labeled as: NEURO TRAY, Pack Number DYNJ55909B
- and 19 more product lines
Ongoing Class II Medical devices
- Recall started
- 8 April 2024
- Reason
- Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2775-2024, Z-2774-2024, Z-2776-2024, Z-2780-2024, Z-2779-2024, Z-2778-2024, Z-2777-2024
- Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY, Pack Name MNS12670A; 2) BREAST BIOPSY KIT, Pack Name DYNDH1512A; 3) CIRCUMCISION TRAY, Pack Name CIT6720; 4) CIRCUMCISION TRA
- Centurion procedure packs, containing Caina syringes, labeled as: 1) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 2) RETINAL INJECTION KIT, Pack Number MNS12465
- Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack Number DYNDH1446A; 2) ARTHROGRAM TRAY, Pack Number MNS11965A; 3) ARTHROGRAPH TRAY, Pack Number MNS12670A; 4) BREAST BIOPSY K
- Centurion procedure packs, containing Caina syringes, labeled as: 1) BREAST BIOPSY KIT, Pack Number DYNDH1512A; 2) CIRCUMCISION KIT, Pack Number CIT6535; 3) CIRCUMCISION KIT, Pack Number CIT7095; 4) CIRCUMCISIO
- Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) CIRCUMCISION TRAY, Pack Number CIT6720; 3) CIRCUMCISION TRAY, Pack Number CIT6720A
- Centurion procedure packs, containing Caina syringes, labeled as: SHAVE KIT, Pack Number MNS8250
- Centurion procedure packs, containing Caina syringes, labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6860A; 2) RETINAL INJECTION KIT, Pack Number MNS12465
Ongoing Class II Medical devices
- Recall started
- 8 April 2024
- Reason
- Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2624-2024, Z-2630-2024, Z-2632-2024, Z-2635-2024, Z-2629-2024, Z-2625-2024, Z-2627-2024, Z-2626-2024, Z-2623-2024, Z-2628-2024, Z-2631-2024, Z-2634-2024 and 1 more
- see RES for description
- Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS PACK , Pack Number DYNJ36932A ; 3) DIALYSIS AV SHUNT #668229-V-LF, Pack Numbe
- Medline procedure packs containing Shenli syringes, labeled as follows: 1) NEURO ANGIO PACK, Part Number DYNDA1431A; 2) CVC INSERT BUNDLE 16CM, Part Number ECVC3260; 3) CENTRAL LINE INSERTION KIT, Part Number ECVC
- Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS981579O ; 2) DR DIULUS INJECTION PACK, Pack Number DYNDA2391; 3) BLOCK KIT , Pack Number DYNDA2508; 4) NERVE BLOCK PAIN PACK, Pack Number DYN
- Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045
- See RES Description
- Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-
- See RES description
- and 5 more product lines
Ongoing Class II Medical devices
- Recall started
- 8 April 2024
- Reason
- Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3056-2024, Z-2990-2024, Z-3050-2024, Z-3038-2024, Z-3023-2024, Z-3047-2024, Z-3030-2024, Z-3003-2024, Z-3013-2024, Z-2984-2024, Z-3010-2024, Z-3037-2024 and 69 more
- Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pack Number 59112; 2) SUTURE SET, Pack Number DYNDL1984; 3) CLOSING PACK, Pack Number DYNJ68267A ; 4) SUTURING KIT, Pack Number MNS15015
- Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ; 2) KIT LEFT HEART-VA MED, Pack Number 132701; 3) KIT MANIFOLD CSTM-RENAISSANC, Pack Number 134085 ; 4) KIT LEFT HEART- L
- Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD; 2) FETAL SURGERY CDS-LF, Pack Number CDS840214P ; 3) OB PROCEDURE-LF , Pack Number CDS981335C ; 4) ROBOTIC PACK-LF , Pack Number
- Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON SUPPLEMENTAL PACK , Pack Number DYNDA3019; 3) L & D PACK-LF , Pack Number DYNJ16121O ; 4) FAMILY PLANNING PACK, Pack Number D
- Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS930092U ; 2) SMALL WOUND TRAY, Pack Number DYNDA1822; 3) RADIOLOGY UTILITY TRAY, Pack Number DYNDA2865; 4) BLOOD CULTURE SET , Pack Number DYN
- Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J ; 2) UROLOGY MINOR CDS , Pack Number CDS980371K ; 3) CIRCUMCISION TRAY 1.1 , Pack Number CIT6260A ; 4) CIRCUMCISION TRAY 1.3 CM
- Medline Convenience kits labeled as: 1) STEREOTACTIC BREAST BIOPSY TRA, Pack Number BT1095 ; 2) BREAST BIOPSY TRAY, Pack Number MNS5070; 3) BREAST BIOPSY TRAY-LF, Pack Number SPEC0058A; 4) BREAST BIOPSY TRAY, Pa
- Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack Number DYNJ32049A ; 3) BREAST BIOPSY PACK, Pack Number DYNJ44987G ; 4) BREAST BIOPSY PACK, Pack
- and 73 more product lines
Ongoing Class II Medical devices
- Recall started
- 8 April 2024
- Reason
- Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
- Distribution
- worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2768-2024, Z-2773-2024, Z-2770-2024, Z-2767-2024, Z-2766-2024, Z-2769-2024, Z-2771-2024, Z-2772-2024
- Centurion procedure kits labeled as: 1) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 2) 5FR 2L PICC LINE TRAY, Pack Number PICC0020; 3) 6" FEMORAL ARTERIAL LINE KIT, Pack Number ART245B; 4) ADVANCED REPAI
- Centurion procedure packs, labeled as: 1) BIOPSY TRAY-LF, Pack Number SPEC4380; 2) CIRCUMCISION TRAY, Pack Number CIT6325; 3) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 4) LUMBAR PUNCTURE TRAY, Pack Number P
- Centurion procedure kits labeled as: 1) BONE MARROW TRAY, Pack Number SPEC0255; 2) CT/ULTRASOUND BIOPSY, Pack Number SPEC0262; 3) FINE LACERATION KIT, Pack Number SUT17215; 4) INFECTION DRIVELINE MANAGEMENT KIT,
- Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) ARTERIAL LINE TRAY-NO CATHETER, Pack Number ART1170; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) ART
- Centurion procedure kits labeled as: 1) BIOPSY KIT, Pack Number DYNDA1466A; 2) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 3) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 4) CUSTOM BIOPSY TRAY, Pack Num
- Centurion procedure kits labeled as: UMBILICAL VESSEL TRAY, Pack Number UVT1100
- Centurion procedure kits, labeled as: 1) BREAST BIOPSY KIT, Pack Number MNS6950A; 2) BREAST BIOPSY PACK, Pack number BT515A
- Centurion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYNDH1349; 2) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) BIOPSY KIT, Pack Number DYNDH1
Ongoing Class I Medical devices
- Recall started
- 8 April 2024
- Reason
- Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
- Distribution
- Worldwide Distribution: US (nationwide) and OUS countries of: AE, AI, BB, CA, CL, CY, DE, GT, HN, JP, MX, MY, PA, PE, PR, SA, SG, TC, TT, VI, PR, TT, MX, BM, ES, NI, DO, GU, CR, AT, CD, DE, DF, W, and ON.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2443-2024, Z-2444-2024, Z-2442-2024
- Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, Pack Number DYNJRA1221A
- Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ; 2) VASCULAR PACK , Pack Number CMPJ11455B ; 3) SALEM CATH LAB-LF , Pack Number DYNJ26938J ; 4) EH PEDIATRIC CATH , Pack
- Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C; 3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C; 4) BASIC DIAGNOST
Ongoing Class II Medical devices
- Recall started
- 8 April 2024
- Reason
- Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2516-2024, Z-2515-2024
- Centurion procedure kits labeled as: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105
- Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A
Ongoing Class II Medical devices
- Recall started
- 22 March 2024
- Reason
- A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Distribution
- Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2694-2024, Z-2701-2024, Z-2695-2024, Z-2704-2024, Z-2703-2024, Z-2699-2024, Z-2708-2024, Z-2710-2024, Z-2697-2024, Z-2709-2024, Z-2702-2024, Z-2696-2024 and 9 more
- LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500
- Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PACEMAKER, REF DYNJ901681D, e) UPPER ENDO KIT, R
- LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K
- Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOPY KIT, REF DYKE1431B; d) ENDOSCOPY KIT, REF DYKE1623B; e) GENERAL LAPAROSCOPY, REF DYNJ90238
- Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B; c) ENT, REF DYNJ909935; d) NASAL SINUS-LF, REF DYNJ902624G; e) ORAL, REF DYNJ902377I; f) PAC
- 1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG
- Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTAL CDS, REF CDS984010B; d) EGD KIT, REF DYK1253578F; e) EGD REG KIT, REF DYKE1830; f) ENDO KIT
- Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DYKC1289F
- and 13 more product lines
Ongoing Class II Medical devices
- Recall started
- 14 March 2024
- Reason
- Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
- Distribution
- US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2228-2024, Z-2230-2024, Z-2226-2024, Z-2232-2024, Z-2231-2024, Z-2224-2024, Z-2229-2024, Z-2227-2024, Z-2225-2024
- Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing component Sterile Curved Kelly Hemostat, Reorder #66175. b. Medline Cath Lab Pack, Pack #DYNJ56
- Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch with component Reorder #DYNJ040408, Kelly Forceps/STD STR Sterile. b. Medline Adult/Child Intubati
- Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.
- Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile. b. Medline Code Cart Drawer 2 Adult Kit, Pack ACC
- Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.
- Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. b. Medline Angiograph
- Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile. b. Medline C-Section, Pack DYNJ902938J, containing
- Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, containing a Pure Pouch component Sterile Sharp/Blunt Scissors 5.5", Reorder #65945 and containing a Pure Pouch component Sterile 5.5" Episiotomy
- and 1 more product lines
Ongoing Class II Medical devices
- Recall started
- 12 March 2024
- Reason
- Products have a lack of sterility assurance.
- Distribution
- US Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC, VA, CA, SD, TN, GA, PA, TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1807-2024, Z-1806-2024
- Namic FLUID DELIVERY SET, REF 91300040
- namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 60080085; e) CONVENIEN
Ongoing Class II Medical devices
- Recall started
- 5 March 2024
- Reason
- Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after the mandatory compliance requirement (ASTM F3186-17, Standard Specification for Adult Portable Bed Rails and Related Products and 16 CFR Part 1270, Safety Standard for Adult Portable Bed Rails ) and failed to meet all mandatory requirements outlined in these standards.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1487-2024, Z-1488-2024
- Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS6800BAMMS
- Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), b) Medline SwivAssist Bar, Model Number MDS6800SWIVRH (individual)
Ongoing Class II Medical devices
- Recall started
- 1 March 2024
- Reason
- Trumpet Needle Guide ring can detach when excessive pressure is applied.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1918-2024, Z-1917-2024
- Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PUDENDAL KIT, REF DYNJRA2210; c) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046; d) PARACERVICAL/PU
- Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience tray
Ongoing Class I Medical devices
- Recall started
- 26 February 2024
- Reason
- Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were also reports the suction pump is difficult to connect or detaches during use.
- Distribution
- Distribution was nationwide. There was government/military distributon. Foreign distribution was made to San Salvador and United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1876-2024
- Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF DYNJ18865, Polyurethane Cuff 6.5 mm ID; (3) REF DYNJ18870, Polyurethane Cuff 7.0 mm ID; (4) REF DY
Ongoing Class II Medical devices
- Recall started
- 26 February 2024
- Reason
- The firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the firms Receiving Dept. accepted these units into inventory
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1459-2024
- Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
Ongoing Class II Medical devices
- Recall started
- 23 February 2024
- Reason
- Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama, Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1444-2024, Z-1451-2024, Z-1429-2024, Z-1438-2024, Z-1453-2024, Z-1452-2024, Z-1446-2024, Z-1434-2024, Z-1440-2024, Z-1455-2024, Z-1443-2024, Z-1435-2024 and 17 more
- Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/B SCISSOR 4-1/2" (I142), Product Code 65940; c) STERILE S/B SCISSOR 5-1/2" (I140), Product Code 65
- Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335
- Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6
- Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), Product Code 66145; c) STERILE STRT KELLY HEMOSTAT (SK8039), Product Code 66170;
- MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724
- MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A
- Centurion STERILE #16 RUBBER BAND, Product Code EB16
- Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNELL RETRACTOR (RR602), Product Code 67525; c) ST. SENN RETRACTOR 3 PRG BLUNT (ST7085), Product Code
- and 21 more product lines
Ongoing Class II Medical devices
- Recall started
- 23 January 2024
- Reason
- Product failed sterility testing.
- Distribution
- US Nationwide distribution in the states of AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI, SC, TN, TX. and VA. There was no foreign/government/military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1295-2024
- CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4 in., 4 dressings per box, 24 boxes per case.
Ongoing Class II Drugs
- Recall started
- 10 January 2024
- Reason
- Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0315-2024
- Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093. NDC: 53329-147-44
Ongoing Class II Medical devices
- Recall started
- 4 January 2024
- Reason
- Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached during transportation. This only affects two lot numbers (96922110001 and 96923100001).
- Distribution
- US, Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1157-2024
- Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
Ongoing Class II Medical devices
- Recall started
- 21 December 2023
- Reason
- Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0967-2024, Z-0968-2024, Z-0965-2024, Z-0964-2024, Z-0963-2024, Z-0969-2024, Z-0966-2024
- MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723
- MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C
- MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A
- MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A
- MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A
- MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194A
- MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B
Ongoing Class II Medical devices
- Recall started
- 20 December 2023
- Reason
- There is stability concern for products dated with a 24-month shelf life. Product is safe and effective up to 12 months shelf life.
- Distribution
- US and territories, S. Korea, Panama, and Dubai
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1180-2024
- These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant with sporicidal, virucidal, bactericidal, and fungicidal activites. MEDLINE MICRO-KILL Bleach GERMICIDAL BLEACH WIPES:
Ongoing Class II Medical devices
- Recall started
- 29 November 2023
- Reason
- Surgical gowns were manufactured with the wrong sleeve.
- Distribution
- Distribution was made to MD, OH, TN, TX, and WI. There was no government/military/foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0711-2024
- Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
Ongoing Class I Medical devices
- Recall started
- 15 November 2023
- Reason
- Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
- Distribution
- Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1090-2024, Z-1124-2024, Z-1118-2024, Z-1134-2024, Z-1123-2024, Z-1102-2024, Z-1122-2024, Z-1116-2024, Z-1114-2024, Z-1104-2024, Z-1096-2024, Z-1119-2024 and 37 more
- MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
- Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G
- Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE, REF SUT12825; b) LACERATION TRAY, REF SUT21580; c) LACERATION TRAY, REF DYNDL1484B;
- Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B; b) NEONATAL PICC LINE INSERTION TRAY, REF CVI2025; c) NEONATAL PICC LINE INSERTION TRAY, REF CVI4570; d) SECONDARY IV STAR
- Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF CDS983913S; c) GYN LAPAROSCOPY CDS, REF CDS983913T; d) GYN LAPAROSCOPY CDS, REF CDS983913U; e)
- MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR CDS, REF CDS983673I; c) C NURSE BAG KIT, REF DYKM1425; d) DAILY DRIVELINE MGMT KIT w/PER, REF DT1
- Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b) LABOR AND DELIVERY, REF DYNJ907794; c) LACERATION TRAY, REF DYNDL1864A; d) OBSTETRICAL, REF DYNJ908877; e) UMC EP VAGINAL DE
- Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; c) PRE OP KIT 1, REF DYKS1377; d) PRE OP KIT 1, REF DYKS1377A
- and 41 more product lines
Ongoing Class II Medical devices
- Recall started
- 3 November 2023
- Reason
- The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
- Distribution
- US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0525-2024, Z-0531-2024, Z-0530-2024, Z-0528-2024, Z-0527-2024, Z-0526-2024, Z-0529-2024
- STERILE PVP SOLUTION, REF DYNDA1907
- STERILE POVIDONE, REF DYNDA2061
- STERILE BETADINE, REF DYNDA1998
- STERILE PVP, REF DYNDA1649
- STERILE STERILE PREP STICK, REF DYNDA1134
- STERILE PVP SLN KIT, REF DYNDM1097
- PVP SOLUTION SING STRL, REF DYNDA1858
Ongoing Class II Medical devices
- Recall started
- 1 November 2023
- Reason
- This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.
- Distribution
- US Nationwide distribution in the state of California.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0310-2024, Z-0311-2024, Z-0314-2024, Z-0313-2024, Z-0312-2024
- ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245
- PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561
- BLOOD CULTURE KIT, REF DYNDH1647B
- 24 BLOOD CULTURE KIT, REF DYNDH1632
- CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562
Ongoing Class II Medical devices
- Recall started
- 19 October 2023
- Reason
- Undeclared latex
- Distribution
- US and Panama
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0535-2024, Z-0533-2024, Z-0534-2024
- Medline Leg bag, REF URO12573
- Medline Leg bag, REF DYND12574
- Medline Leg bag, REF DYND12578
Ongoing Class I Medical devices
- Recall started
- 16 October 2023
- Reason
- The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have been incidents of the tracheostomy brush bristles detaching prior to use in the packaging and/or during use.
- Distribution
- US Nationwide distribution including Puerto Rico. OUS (Foreign) distribution was made to Canada, Panama, and United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0561-2024, Z-0562-2024, Z-0563-2024
- Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Sterile; (2) Medline Tracheostomy Clean and Care Tray, REF DYND4061030, Sterile; (3) Medline Basic
- (1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human Use.
- (1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Training Purposes Only, Not For Human Use.; and (2) Nursing Tote Kit, SKU #EDUC5056A, Case UPC 40195327153695, Non-sterile, For Training Purposes O
Terminated Class II Drugs
- Recall started
- 4 October 2023
- Terminated
- 30 September 2024
- Reason
- CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0091-2024
- Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, NDC: 533
Ongoing Class I Medical devices
- Recall started
- 4 August 2023
- Reason
- Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2514-2023
- HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
Ongoing Class II Medical devices
- Recall started
- 3 August 2023
- Reason
- 4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissors could compromise the sterile barrier system by puncturing large and/or small holes that may not be visible to the user.
- Distribution
- Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Canada, Hong Kong, Taiwan, Singapore
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2595-2023
- MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
Ongoing Class II Medical devices
- Recall started
- 3 August 2023
- Reason
- Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
- Distribution
- US
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0120-2024, Z-0118-2024, Z-0119-2024, Z-0117-2024
- MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.
- MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator, REF LF1944CR. electrosurgical instrument
- MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF4418CR. electrosurgical instrument
- MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF1844CR. electrosurgical instrument
Ongoing Class II Medical devices
- Recall started
- 3 July 2023
- Reason
- The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit.
- Distribution
- US Nationwide distribution in the state of Illinois.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2366-2023
- Total Hip Kit, REF DYNJ903275S; surgical convenience kit
Ongoing Class II Medical devices
- Recall started
- 23 May 2023
- Reason
- The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2649-2023
- Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.
Ongoing Class II Medical devices
- Recall started
- 18 May 2023
- Reason
- Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- Distribution
- Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2176-2023, Z-2169-2023, Z-2163-2023, Z-2195-2023, Z-2205-2023, Z-2161-2023, Z-2203-2023, Z-2159-2023, Z-2202-2023, Z-2194-2023, Z-2204-2023, Z-2192-2023 and 40 more
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F; b) ENDOVENOUS CORE PACK, Model Number DYNJ62557; c) ENSEMBLE CATHETER DIALYSE-LF, Mode
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214Q; b) MINOR PROCEDURE TRAY, Model Number DYNDA2418; c) CLOSUREFAST PROCEDURE PACK-
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q; b. PERCUTANEOUS VASCULAR CDS, Model Number CDS840487I; c. BAPTIST SOUTH
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI4510; b) VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number STCVC01145B; c) VANTEX TRI
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I;
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number DYNJ55252C; b) CATH LAB PACK, Model Number DYNJ55455A; c) CATH LAB 2, Model Number DYNJ55680A; d
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: BREAST BIOPSY TRAY, Model Number SPEC0130C
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH, Model Number 00-401318M; b) ANGIOGRAPHY OR, Model Number CDS984944C; c) ANGIOGRAM, Model Number
- and 44 more product lines
Ongoing Class II Medical devices
- Recall started
- 18 May 2023
- Reason
- Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
- Distribution
- Worldwide distribution - US Nationwide and the country of Panama.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2134-2023, Z-2133-2023, Z-2131-2023, Z-2132-2023, Z-2135-2023, Z-2137-2023, Z-2136-2023
- MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L
- MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A
- MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
- MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number CDS980089O
- MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A
- MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I; d) BSHR TOTAL KNEE-LF, Model
- MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PACK, Model Number VAL050EEPKB
Ongoing Class II Medical devices
- Recall started
- 15 May 2023
- Reason
- Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2305-2023, Z-2329-2023, Z-2321-2023, Z-2336-2023, Z-2306-2023, Z-2334-2023, Z-2338-2023, Z-2298-2023, Z-2328-2023, Z-2333-2023, Z-2309-2023, Z-2300-2023 and 38 more
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FISTULA, Model Number: DYNJ65711; b. ACCESS CATHETER, Model Number: DYNJ64141A; c. ACCESS PICC P
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PROBE COVER PACK, Model Number: DYNDA1219
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755B; b. PEDIATRIC MAX BARRIER KIT-LF, Model Number: DY
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. EGG RETRIEVAL PACK, Model Number: DYNJ66291B; b. FETAL SURGERY CDS-LF, Model Number: CDS840214P;
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. SHY IR PICC PACK, Model Number: DYNJ57112; b. STANDARD PICC II-LF, Model Number: DYNJSPICC2, PICCN
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. C V MINOR PACK, Model Number: DYNJ64862A; b. DBD-C SECTION ADM, Model Number: DYKL1816; c. FET
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAPHY PACK, Model Number: DYNJ65963A; b. ARTHOGRAM TRAY, Model Number: PAIN1524B; c. ART
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C; b. CRMC TUNNEL CATH TRAY-LF, Mode
- and 42 more product lines
Ongoing Class II Medical devices
- Recall started
- 12 May 2023
- Reason
- The scissors were manufactured without a tip protector resulting in the scissors breaking through the semi-rigid plastic tray compromising sterility.
- Distribution
- US Nationwide distribution. There was government distribution but no military or foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2206-2023
- Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000
Ongoing Class II Medical devices
- Recall started
- 3 May 2023
- Reason
- Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization dose audit failure on the wound gel and not augmenting the dose after failure per ISO 11137.
- Distribution
- Worldwide distribution - US Nationwide and the countries of SINGAPORE, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES, DUBAI, CHINA, PANAMA, CANADA, SAUDI ARABIA, BERMUDA, COLOMBIA, MAURITIUS, KUWAIT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1982-2023
- MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
Ongoing Class II Medical devices
- Recall started
- 21 April 2023
- Reason
- The kits were damaged by water.
- Distribution
- Distribution was made to California. There was no foreign/government/military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1646-2023
- Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B.
Ongoing Class II Medical devices
- Recall started
- 28 March 2023
- Reason
- The case and each (i.e. packet) labels for the DYND3000xxP series do not include an expiration date, however, the lubricating jelly (MDS032280) included in the DYNDP3000xxP series is labeled with an expiration date.
- Distribution
- Worldwide distribution - US Nationwide and the country of Bermuda.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2227-2023
- DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
Ongoing Class II Medical devices
- Recall started
- 2 March 2023
- Reason
- The CirClamp subassembly found in the kit was the incorrect size.
- Distribution
- US Nationwide distribution in the states of CA and TX. There was no foreign/government/military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1407-2023
- Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
Ongoing Class II Medical devices
- Recall started
- 27 December 2022
- Reason
- The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.
- Distribution
- US Nationwide distribution in the states of AR, CO, and GA. There was no foreign/military/government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1163-2023, Z-1161-2023, Z-1162-2023
- (1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor PN: 930815NS; and (2) Medline Sterile Hand Pack, Item DYNJ63380C, 3 kits per case, conta
- Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with Chlorhexidine Gluconate (CHG), DRSG Biopatch 1IN NS, VPN: 10150;
- (1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicator, Vendor PN: 930715NS; (2) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ02
Ongoing Class II Medical devices
- Recall started
- 23 December 2022
- Reason
- The kit contained an expired component.
- Distribution
- US Nationwide distribution in the states of NY, IN, FL, NJ, IL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1015-2023
- CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760
Ongoing Class II Medical devices
- Recall started
- 22 December 2022
- Reason
- The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have observed screw failure due to excessive torque.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1047-2023, Z-1045-2023, Z-1046-2023
- MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
- MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008
- MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008
Ongoing Class II Medical devices
- Recall started
- 7 December 2022
- Reason
- The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1125-2023, Z-1117-2023, Z-1114-2023, Z-1111-2023, Z-1123-2023, Z-1113-2023, Z-1112-2023, Z-1109-2023, Z-1124-2023, Z-1118-2023, Z-1119-2023, Z-1115-2023 and 8 more
- Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
- Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY, Reorder Number MNS9065
- Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224B
- Surgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD
- Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYNDL1643A
- Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PICC TRAY, Reorder Number CVI4685
- Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827
- Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122A
- and 12 more product lines
Ongoing Class II Medical devices
- Recall started
- 18 November 2022
- Reason
- Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.
- Distribution
- US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MD, MI, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0930-2023
- Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL, Item Number: CISION10CS; b. STERILE BLADE NO. 10 CARBON STEEL RIB, Item Number: CISION10CSR;
Ongoing Class II Medical devices
- Recall started
- 17 November 2022
- Reason
- Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1077-2023, Z-1064-2023, Z-1087-2023, Z-1072-2023, Z-1092-2023, Z-1067-2023, Z-1094-2023, Z-1074-2023, Z-1062-2023, Z-1071-2023, Z-1065-2023, Z-1095-2023 and 26 more
- Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. ACH PLASTICS BREAST-LF e. NE BREAST RECON CDS f. PLASTIC SURGERY CDS g. MINOR PLAS
- UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
- Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK
- Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH PARA/THYROIDECTOMY CDS g. CAM ENDOSCOPIC SINUS/SEPTO CDS h. HEAD AND N
- Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d. C-SECTION CDS e. MAJOR ORTHO CDS-LF f. C-SECTION CDS g. C-SECTION CDS h. C-SECTION PROCEDURE i.
- Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALVE PACK i. OPEN HEART CDS-3 j. OPEN HEART
- Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOTICS PACK-LF e. ROBOTIC PACK f. PELVISCOPY PACK-LF g. CUSTOM LITHOTOMY ROBOT PACK
- Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c. BASIC LAPAROSCOPY CDS d. LAPAROSCOPY CDS-LF e. GENERAL LAPAROSCOPY PROCEDURE f. LAP CHOLE CDS g. COLO-RECTAL CDS-LF h. MA
- and 30 more product lines
Ongoing Class II Medical devices
- Recall started
- 17 November 2022
- Reason
- Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
- Distribution
- US Nationwide distribution in the states of AR, MD, WA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1032-2023, Z-1033-2023, Z-1029-2023, Z-1035-2023, Z-1034-2023, Z-1031-2023, Z-1030-2023
- Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
- Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case
- Non-sterile procedural trays labeled as CRANI, 2 per case
- Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case
- Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case
- Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case
- Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case
Ongoing Class II Medical devices
- Recall started
- 30 September 2022
- Reason
- Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
- Distribution
- US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0167-2023, Z-0164-2023, Z-0166-2023, Z-0165-2023, Z-0157-2023, Z-0160-2023, Z-0162-2023, Z-0156-2023, Z-0155-2023, Z-0161-2023, Z-0163-2023, Z-0158-2023 and 1 more
- CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Convenience kit used in medical procedures.
- MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.
- MEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical procedures.
- MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in medical procedures.
- BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical procedures.
- BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures.
- MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical procedures.
- BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical procedures.
- and 5 more product lines
Ongoing Class II Medical devices
- Recall started
- 9 September 2022
- Reason
- Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.
- Distribution
- US Nationwide distribution in the state of California.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0120-2023, Z-0121-2023, Z-0124-2023, Z-0122-2023, Z-0123-2023
- MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245
- MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561
- MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756
- MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592
- MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632
Terminated Class II Medical devices
- Recall started
- 7 September 2022
- Terminated
- 4 March 2026
- Reason
- One lot of chest tube insertion trays, containing a silk suture component that is restricted to 1 cycle of sterilization, was processed though 2 cycles.
- Distribution
- US Nationwide distribution in the states of CA and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0106-2023
- CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
Terminated Class II Medical devices
- Recall started
- 1 September 2022
- Terminated
- 26 January 2026
- Reason
- Impacted Venclose Procedure Packs contain a 12cm introducer/sheath component, either component #128626 - SET INTRO 7FX12CM FITS 0.018 or component #137339 - SET INTRO 6.5FX12CM FITS 0.018, instead of a 7cm introducer/sheath, component #137340 - SET INTRO 6.5FX7CM FITS 0.018
- Distribution
- CA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0088-2023
- VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
Ongoing Class II Medical devices
- Recall started
- 3 August 2022
- Reason
- Potential for the suction catheter to come apart from the green connector near the thumb valve. The connector is coming apart from the assembled device when pulling the catheter out of the artificial airway in the patient suctioning process.
- Distribution
- Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico. International distribution to Canada, Chile, Colombia, Pa
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1857-2022, Z-1856-2022, Z-1855-2022
- MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. TRACH T-PIECE, 14 Fr, Item Number/REF: DYNCPTP14;
- MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. TRACH DOUBLE SWIVEL, 12 Fr, Item Number/REF:
- MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. ET LENGTH DOUBLE SWIVEL, 12 Fr, Item Number/REF: D
Ongoing Class II Medical devices
- Recall started
- 29 June 2022
- Reason
- stability failure
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1493-2022
- MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES, Model numbers MSC351420AN, MSC351420ANH, MSC351420ANZ, MSC351430A, MSC351430AZ
Ongoing Class II Medical devices
- Recall started
- 11 May 2022
- Reason
- Product lid (which houses a blade) is coming unhinged from the base, thus exposing the blade.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Panama, and Hongkong.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1287-2022
- Medline Pill Splitters; 1 each/box; 144 boxes/carton
Ongoing Class II Medical devices
- Recall started
- 21 April 2022
- Reason
- Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
- Distribution
- US and Panama
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1218-2022, Z-1219-2022, Z-1220-2022, Z-1221-2022, Z-1217-2022
- MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS
- MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW
- MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK215FS
- MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS
- MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE
Terminated Class II Medical devices
- Recall started
- 9 March 2022
- Terminated
- 26 May 2026
- Reason
- The mask cuff may disconnect from the device's breathing tube.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0941-2022
- Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
Terminated Class II Medical devices
- Recall started
- 8 March 2022
- Terminated
- 27 February 2023
- Reason
- The product was stored incorrectly due to improper storage controls which may lead to delayed results.
- Distribution
- Distribution was made to AL, FL, NE OH, TX, WA, and WI. There was no foreign/military/government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0933-2022
- Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604, IVD.
Terminated Class II Medical devices
- Recall started
- 8 March 2022
- Terminated
- 20 March 2023
- Reason
- Product was improperly store which may cause a delay in results.
- Distribution
- US distribution only - AL, CA, FL, GA, IL, IN, LA, MO, MS, NC, NE, NY, OH, PA, VA, and WA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0932-2022
- Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)
Terminated Class II Medical devices
- Recall started
- 4 March 2022
- Terminated
- 20 March 2023
- Reason
- Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.
- Distribution
- US Nationwide Distribution was made to KY, OK, and TX. There was no foreign/government/military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0898-2022
- Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box,
Terminated Class II Medical devices
- Recall started
- 25 January 2022
- Terminated
- 9 January 2023
- Reason
- The product was incorrectly shipped at room temperature rather than refrigerated.
- Distribution
- US Distribution was made to IL, FL, LA, MS, NC, OH, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0678-2022
- meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human sto
Ongoing Class II Medical devices
- Recall started
- 29 December 2021
- Reason
- Micro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama and Bermuda.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0696-2022
- MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes
Ongoing Class II Medical devices
- Recall started
- 15 December 2021
- Reason
- The product contains natural rubber latex but the label states that it does not.
- Distribution
- US and Bahamas, Bermuda, Panama, Lebanon, Barbados, Honduras, Anguilla
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0633-2022
- CURAD REUSABLE GEL HOT/COLD PACK
Terminated Class II Medical devices
- Recall started
- 1 December 2021
- Terminated
- 9 January 2023
- Reason
- Product stored incorrectly in temperature controlled setting instead of refrigeration.
- Distribution
- US Nationwide distribution in the state of California.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0554-2022
- HARDY DIAGNOSTICS CatScreen, 25dsk/vial
Terminated Class II Medical devices
- Recall started
- 1 December 2021
- Terminated
- 13 February 2023
- Reason
- Product stored incorrectly in temperature controlled setting instead of refrigeration.
- Distribution
- US Nationwide distribution in the states of California and Massachusetts.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0552-2022
- Premier Rotaclone, Rx only
Terminated Class II Medical devices
- Recall started
- 1 December 2021
- Terminated
- 13 February 2023
- Reason
- Product stored incorrectly in temperature controlled setting instead of refrigeration.
- Distribution
- US Nationwide distribution in the states of Colorado, Florida, New York, North Carolina, and Texas.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0656-2022
- Michels Transport Medium, 20ML Prefilled Cont
Terminated Class II Medical devices
- Recall started
- 30 November 2021
- Terminated
- 6 January 2023
- Reason
- Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.
- Distribution
- US Nationwide distribution in the states of IL, OH, MS, and PA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0404-2022
- Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
Terminated Class II Medical devices
- Recall started
- 22 October 2021
- Terminated
- 4 January 2023
- Reason
- Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the results from this impacted Calcium reagent will not be provided due to probable Quality Control failure. A delay in diagnosis may be experienced with repeat testing resulting in patient (customer) inconvenience, pain, and cost of the repeat blood draw and testing. All HII1220001954 product shipped/stored at a Medline branch between July 2021 and August 2021 in the identified lots were incorrectly stored and shipped. Six (6) boxes have been shipped to end users at room temperature instead of refrigerated (ice). Five (5) boxes are on hold at a Medline warehouse.
- Distribution
- US Distribution to North Carolina.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1140-2022
- ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.