Bloomington, IN, United States

Cook Inc. recalls

56 recalls recorded since 2018, most recently on 16 September 2026. 17 are listed as ongoing. Status and classification are as published by the FDA.

Recalls56

Ongoing (FDA)17

Terminated or completed39

Class I (FDA)8

Ongoing Class II Medical devices

Recall started: 16 September 2026
Reason: The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur as a result of this issue include increased procedural time and inadequate treatment.
Distribution: US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland.
Initiated: Voluntary: Firm initiated
Recall number: Z-0163-2027

Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26, Order Number (GPN) G16112

Ongoing Class I Medical devices

Recall started: 2 April 2026
Reason: Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Distribution: US distribution nationwide. OUS distribution to Brunei, Brazil, Canda, China, Colombia, Costa Rica, Hong Kong, Israel, India, Japan, South Korea, Macau, New Zealand, Singapore, El Salvador, Taiwan, Uruguay
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1934-2026, Z-1935-2026, Z-1936-2026

Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., po
Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and
Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-100-P-10S-VCF

Ongoing Class II Medical devices

Recall started: 5 March 2026
Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Distribution: Worldwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1778-2026, Z-1785-2026, Z-1784-2026, Z-1791-2026, Z-1780-2026, Z-1777-2026, Z-1789-2026, Z-1788-2026, Z-1775-2026, Z-1790-2026, Z-1779-2026, Z-1786-2026 and 6 more

COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419
Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665.
COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108
COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.
COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Refere
COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792
COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800; Reference Part Number C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, Order Number G44809; Reference Pa
COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754; Reference Part Number C-UDLM-40
and 10 more product lines

Ongoing Class II Medical devices

Recall started: 26 November 2025
Reason: Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
Distribution: Worldwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0993-2026, Z-0995-2026, Z-0994-2026

Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3) KCFW-10.0-35-45-RB-HFANL0-HC; 4) KCFW-10.0-35-45-RB-HFANL1-HC; 5) KCFW-12.0-3
R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagnostic and interven

Ongoing Class I Medical devices

Recall started: 15 May 2025
Reason: Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
Distribution: Worldwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1902-2025

Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves

Ongoing Class II Medical devices

Recall started: 17 April 2025
Reason: Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Distribution: Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1786-2025, Z-1787-2025

Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,

Ongoing Class II Medical devices

Recall started: 17 April 2025
Reason: Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
Distribution: worldwide - No US distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1762-2025

Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN MWCE-18S-3/2-TORNADO (GPN G08261), RPN MWCE-18S-3/2-TORNADO-081800 (GPN

Ongoing Class II Medical devices

Recall started: 14 October 2024
Reason: Devices from the affected device lots have labels that state the incorrect expiration dates.
Distribution: International Distribution to: Korea only
Initiated: Voluntary: Firm initiated
Recall number: Z-0499-2025

Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789

Ongoing Class II Medical devices

Recall started: 8 October 2024
Reason: Affected device lots have labels that state the incorrect expiration dates.
Distribution: Worldwide - US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0347-2025, Z-0346-2025

Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G

Ongoing Class II Medical devices

Recall started: 16 September 2024
Reason: Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.
Distribution: International distribution to the country of Australia.
Initiated: Voluntary: Firm initiated
Recall number: Z-0045-2025

Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with a Check Flo valve.

Ongoing Class II Medical devices

Recall started: 15 May 2024
Reason: Product labels state the incorrect expiration dates that extends beyond their true expiration date
Distribution: MA Foreign: Spain, and Netherlands
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2222-2024, Z-2223-2024

Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direc
Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by

Ongoing Class II Medical devices

Recall started: 1 March 2024
Reason: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Distribution: Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1528-2024, Z-1530-2024, Z-1529-2024, Z-1527-2024, Z-1526-2024, Z-1532-2024, Z-1531-2024, Z-1525-2024

Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REFERENCE PART NUMBER
Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. 1
Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. REFERENCE PART NUMBER (R
Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. REFERENCE PART NUMBER (RPN): DTVN-5.0-19-10.0- YUEH ORDER NUMBER (GPN): G09490
Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal system REFERENC
Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems.
Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, b
Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 G01559 2) DCHN-18-10.0-U G05040 3) DCHN-18-15.0 G00850 4) DCHN-22-10.0 G00852 5) DCHN-22-10.0-U

Ongoing Class I Medical devices

Recall started: 7 April 2023
Reason: There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This resulted in an unsecure connection between the device connector and circuit components, cap, or accessories.
Distribution: Worldwide distribution - US Nationwide.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1428-2023, Z-1427-2023

Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720), C-PTISYJ-100-HC-G-NA-FLEX8.5 (G57721), C-PTISY-100-HC-G-
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PTIS-100-HC-G-NA-FLEX8

Ongoing Class II Medical devices

Recall started: 16 August 2022
Reason: Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1833-2022, Z-1835-2022, Z-1844-2022, Z-1836-2022, Z-1825-2022, Z-1840-2022, Z-1842-2022, Z-1824-2022, Z-1832-2022, Z-1831-2022, Z-1830-2022, Z-1843-2022 and 12 more

Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902 TSCF-21-260-3 G00455 THSCF-25-260-3 G02384 TSCF-25-145-3 G00466 THSCF-35-80-3 G04069 THSCF-3
Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-18-40-0-2-HTS G26925
Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0-50-ST G02464 C-CTU14.0-30-ST G02898
Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561
Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735)
Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-ROSEN G01264 THSCF-35-145-1.5-ROSEN G01261
Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874)
and 16 more product lines

Ongoing Class II Medical devices

Recall started: 19 July 2022
Reason: Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Distribution: Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1715-2022, Z-1708-2022, Z-1709-2022, Z-1718-2022, Z-1717-2022, Z-1711-2022, Z-1706-2022, Z-1710-2022, Z-1713-2022, Z-1712-2022, Z-1707-2022, Z-1716-2022 and 1 more

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
and 5 more product lines

Completed Class II Medical devices

Recall started: 25 May 2022
Reason: The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a prolonged procedure, or particulate entering the bloodstream which may result in pulmonary embolism or ischemia.
Distribution: US Nationwide. Brazil, Canada,
Initiated: Voluntary: Firm initiated
Recall number: Z-1362-2022

Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

Ongoing Class II Medical devices

Recall started: 5 May 2022
Reason: The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1241-2022, Z-1242-2022, Z-1240-2022

Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338 MWCE-18-7-2-NESTER-01 G47337 MWCE-18-7-5-NESTER-01 G4734
Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWCE-18S-4/2-TORNADO-01 G47417 MWCE-18S-3/
Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)

Terminated Class II Medical devices

Recall started: 12 November 2021
Terminated: 26 April 2024
Reason: Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
Distribution: AL, AZ, CA, FL, GA, KS, MI, MO, MN, NC, NY, OK, TX Foreign: BE, CH, DE, ES, FR, GB,GU, IT, ZA
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0388-2022, Z-0387-2022

Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and ne
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and n

Ongoing Class II Medical devices

Recall started: 13 October 2021
Reason: Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.
Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, CA, IN, LA, MS, MT, NC, NY, OR, PA, WA and the countries of France, Italy, and Mexico.
Initiated: Voluntary: Firm initiated
Recall number: Z-0414-2022

Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.

Terminated Class II Medical devices

Recall started: 8 October 2021
Terminated: 14 February 2024
Reason: Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death.
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0223-2022, Z-0222-2022

Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

Terminated Class II Medical devices

Recall started: 28 September 2021
Terminated: 28 February 2024
Reason: Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and viewed under fluoroscopy, leading to increased procedural time.
Distribution: Domestic distribution to AR AZ CT FL GA IL LA MA ME MN ND NJ NY OH PA TX WA. Foreign distribution to Germany, Finland, Italy, Netherlands, and Switzerland.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0186-2022, Z-0185-2022

Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with
Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.

Terminated Class II Medical devices

Recall started: 4 January 2021
Terminated: 16 September 2021
Reason: Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation.
Distribution: FL, KY, MD, NS, NY, PA, TX Foreign: Canada, Switzerland
Initiated: Voluntary: Firm initiated
Recall number: Z-0960-2021

Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent Reference Part Number (RP

Terminated Class I Medical devices

Recall started: 24 November 2020
Terminated: 7 September 2022
Reason: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Distribution: US Nationwide Distribution including states of: AK, CT, IA, LA, MO, NH, OK, TN, WI, AL, DC, ID, MA, MS, NJ, OR, TX, WV, AR, DE, IL, MD, MT, NM, PA, UT, WY, AZ, FL, IN, ME, NC, NV, RI, VA, CA, GA, KS, MI, ND, NY, SC, VT, CO, HI, KY, MN, NE, OH, SD, WA and Global Distribution to: AU, SG, Austria, Belg
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0598-2021, Z-0606-2021, Z-0599-2021, Z-0596-2021, Z-0608-2021, Z-0591-2021, Z-0610-2021, Z-0607-2021, Z-0605-2021, Z-0601-2021, Z-0600-2021, Z-0609-2021 and 9 more

Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding cor
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding cor
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding cor
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding cor
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding cor
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding cor
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G31133 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding cor
and 13 more product lines

Terminated Class I Medical devices

Recall started: 22 October 2020
Terminated: 2 September 2021
Reason: Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide.
Distribution: US distribution to AZ, IA, IN, MA, and ND.
Initiated: Voluntary: Firm initiated
Recall number: Z-0399-2021

Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devic

Terminated Class II Medical devices

Recall started: 31 August 2020
Terminated: 1 July 2021
Reason: The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of being updated and will be provided with orders placed following implementation.
Distribution: Worldwide distribution - US Nationwide.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0106-2021, Z-0105-2021

Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail catheter and stent, retention disc with pull tie, and a 10 French,
Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22 gage, 5 cm Chiba Needle; an 18 gage, 5 cm trocar needle; an .038-inch (.97 mm) diameter, 30 cm PTFE

Terminated Class II Medical devices

Recall started: 11 August 2020
Terminated: 28 July 2021
Reason: May contain excess glue within the handle of the delivery system, resulting in an inability to fully deploy the graft via the standard method or troubleshooting deployment method provided in the IFU
Distribution: Foreign Only: Canada SWEDEN AUSTRIA Belgium CZECH REPUBLIC DENMARK ESPA¿A FINLAND France GERMANY GREECE HUNGARY IRELAND ISRAEL Italia Nederland NORWAY POLAND PORTUGAL REUNION SERBIA SLOVENIA SOUTH AFRICA SWEDEN UNITED ARAB EMIRATES UNITED KINGDOM AUSTRALIA Hong Kong J
Initiated: Voluntary: Firm initiated
Recall number: Z-2964-2020

Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22

Terminated Class II Medical devices

Recall started: 30 July 2020
Terminated: 4 November 2021
Reason: Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm Ureteral Stent Set ;pouch label reflects the packaged product.
Distribution: International distribution to the country of Australia.
Initiated: Voluntary: Firm initiated
Recall number: Z-2971-2020

Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder

Terminated Class II Medical devices

Recall started: 2 June 2020
Terminated: 5 May 2022
Reason: Identified products may contain a damaged bushing within the delivery system, which could potentially result in difficulty or an inability to fully deploy the graft via the standard method provided in the IFU.
Distribution: Foreign distribution to the countries of Canada, Chile, Argentina, Colombia, Great Britain, AUSTRIA Belgium. CZECH REPUBLIC DENMARK ESPA¿A France GERMANY GREECE HUNGARY ICELAND IRELAND ISRAEL Italia MARTINIQUE Nederland NORWAY POLAND PORTUGAL SERBIA SOUTH AFRICA SWEDEN UNITED KI
Initiated: Voluntary: Firm initiated
Recall number: Z-2546-2020

Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endov

Terminated Class II Medical devices

Recall started: 30 April 2020
Terminated: 29 March 2021
Reason: The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.
Distribution: Worldwide distribution including distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Washington DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minn
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2203-2020, Z-2204-2020

Pressure Monitoring Set, C-PMS, G02838
Pressure Monitoring Tray, C-PMSY, G02854

Terminated Class II Medical devices

Recall started: 15 April 2020
Terminated: 15 April 2024
Reason: The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon delivery system prior to deployment. Use of affected product may lead to increased procedural time and additional intervention to remove a stent that dislodged within an unintended location.
Distribution: Domestic distribution to OH, IA, VA, and NC. Foreign distribution to Canada.
Initiated: Voluntary: Firm initiated
Recall number: Z-1940-2020

Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel with a slotted tube configuration. It is pre-mounted on an over-the-wi

Terminated Class II Medical devices

Recall started: 6 March 2020
Terminated: 18 December 2020
Reason: The printed expiration dates are incorrect.
Distribution: The products were distributed to the following US states: CO, DE, MD, MN, NC, NV, and WV. The products were distributed to the following foreign countries: Canada.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1566-2020, Z-1565-2020

Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order Number G48053
Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643

Terminated Class II Medical devices

Recall started: 16 January 2020
Terminated: 12 November 2020
Reason: The firm has identified factors which contributed to failures relating to thrombus formation and/or lumen occlusion reports, and is highlighting to customers key points of the IFU pertaining to the prevention of these factors. In addition, the firm has updated the Planning and Sizing Worksheet to include associated information.
Distribution: Foreign distribution only. Distributed worldwide.
Initiated: Voluntary: Firm initiated
Recall number: Z-1355-2020

Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.

Terminated Class II Medical devices

Recall started: 27 December 2019
Terminated: 23 November 2020
Reason: Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly.
Distribution: Nationwide domestic distribution. Foreign distribution to Australia, Belgium, Canada, China, Colombia, Denmark, France, Germany, Italy, Korea, Netherlands, New Zealand, Peru, Russia, Spain, Sweden, and United Kingdom.
Initiated: Voluntary: Firm initiated
Recall number: Z-0815-2020

Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-CLDM-HC, UL T7.0-35-25-P-5S-CLDM-HC

Terminated Class I Medical devices

Recall started: 8 November 2019
Terminated: 1 February 2021
Reason: A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).
Distribution: Distribution to US states of AL, CA, CT, FL, GA, IL, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, and VA, and Brazil.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0588-2020, Z-0590-2020, Z-0589-2020, Z-0587-2020

CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.
CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.
CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.
CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.

Terminated Class II Medical devices

Recall started: 21 October 2019
Terminated: 30 June 2020
Reason: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0435-2020, Z-0471-2020, Z-0487-2020, Z-0483-2020, Z-0479-2020, Z-0456-2020, Z-0441-2020, Z-0472-2020, Z-0452-2020, Z-0426-2020, Z-0427-2020, Z-0439-2020 and 59 more

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiograph
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiograph
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiograph
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiograph
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiograph
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiograph
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiograph
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiograph
and 63 more product lines

Terminated Class II Medical devices

Recall started: 3 October 2019
Terminated: 13 May 2020
Reason: Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected product is used include increased procedural time, the need for a repeat embryo transfer procedure, or the need for a patient to undergo an additional IVF cycle.
Distribution: No US distribution. The products were distributed to the following foreign countries: Belgium, Denmark, Germany, Italy, Netherlands, Norway, Poland, Republic of Macedonia, Slovenia, Spain, and Switzerland.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0415-2020, Z-0416-2020

Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.

Terminated Class II Medical devices

Recall started: 17 September 2019
Terminated: 21 May 2020
Reason: Lidstock perforation line may be over the sterile area of the tray, when it should be on the lip of the tray, potentially compromising the sterility of the device.
Distribution: US Nationwide distribution in the states of CA, FL, IN, MI, MT, NC, NY, OH.
Initiated: Voluntary: Firm initiated
Recall number: Z-0506-2020

Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothorax Set is used for the relief of simple, spontaneous, iatrogenic, and tension pneumothorax.

Terminated Class I Medical devices

Recall started: 24 May 2019
Terminated: 31 October 2019
Reason: Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, and balloon fragmentation in the patient.
Distribution: Worldwide Distribution - US Nationwide The affected product was distributed to the following states: FL, OH, WA. The products were distributed to the following foreign countries: Belgium, Denmark, Finland, Germany, Italy, Netherlands, Norway, Poland, South Africa, Spain, Sweden, Switzerland, Un
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1758-2019, Z-1756-2019, Z-1757-2019

Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35257 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for per
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percu
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percu

Terminated Class II Medical devices

Recall started: 2 May 2019
Terminated: 23 August 2019
Reason: The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product.
Distribution: No distribution in the US. Products were distributed to the following foreign countries: China.
Initiated: Voluntary: Firm initiated
Recall number: Z-1780-2019

Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT

Terminated Class II Medical devices

Recall started: 26 April 2019
Terminated: 8 November 2019
Reason: may contain a damaged gray safety lock knob, which could potentially result in difficulty or an inability to fully deploy the graft via the standard or troubleshooting method provided in the Instructions for Use (IFU). Potential adverse events that may occur if an affected product is used include a prolonged procedure and open surgical intervention.
Distribution: No US distribution. Product distributed to the following foreign countries: Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile Columbia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Morocco, Netherlands, Norway, Poland, Port
Initiated: Voluntary: Firm initiated
Recall number: Z-1844-2019

Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIM

Terminated Class II Medical devices

Recall started: 22 April 2019
Terminated: 5 May 2020
Reason: Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.
Distribution: Nationwide Foreign: Australia Canada Austria Belgium Denmark Germany Spain Finland France Martinique French Polynesia Switzerland Ireland Italy Netherlands Poland Sweden United Kingdom Hong Kong New Zealand Chile Colombia Israel Russian Federation Czech Republic Greece Jo
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1369-2019, Z-1370-2019

Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr 003500 G14916; 6.0 Fr 003600 G14836; 7.0 Fr 003700 G14837; 8.0 Fr 003800 G14844; Set with AQ¿ Hydrophilic Coating PRODU
Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr SIPSF-050018-59 G32774

Terminated Class II Medical devices

Recall started: 9 April 2019
Terminated: 28 April 2020
Reason: Affected products may have been manufactured with the catheter distal end hole too small
Distribution: Domestically: OH; Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA, AUSTRALIA, HONG KONG, INDIA & KOREA
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1725-2019, Z-1724-2019, Z-1722-2019, Z-1723-2019

Thoracentesis Set, RPN C-THS-850, Order # G03286
Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030
Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282
Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284

Terminated Class I Medical devices

Recall started: 1 February 2019
Terminated: 30 June 2020
Reason: The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion.
Distribution: US nationwide and Canada. US distribution to the following states: AZ, FL, IL, IN, KS, MA, MI, MO, PA, SC, TN, and WA. The products were distributed to the following foreign countries: Canada.
Initiated: Voluntary: Firm initiated
Recall number: Z-0979-2019

Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.

Terminated Class II Medical devices

Recall started: 4 January 2019
Terminated: 29 May 2020
Reason: The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Distribution: Domestic distribution to nationwide US. Foreign distribution to Australia, Belgium, Bolivia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, French Polynesia, Germany, Guatemala, Honduras, Hungary, India, Ireland, Italy, Japan, Korea, Luxembourg, Malay
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0977-2020, Z-0962-2020, Z-0966-2020, Z-0972-2020, Z-0970-2020, Z-0967-2020, Z-0975-2020, Z-0974-2020, Z-0964-2020, Z-0971-2020, Z-0963-2020, Z-0959-2020 and 8 more

Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877 G49879 G49881 G49882 G49887 G49888
PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10
Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter, Global Product No. G19108 G14587 G15302 G14326
Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823
Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844
Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649
Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128
Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G14885 G14887 G17151
and 12 more product lines

Terminated Class II Medical devices

Recall started: 21 December 2018
Terminated: 30 April 2020
Reason: The products were manufactured with longer than specified sheaths.
Distribution: The products were distributed to the following US states: CA, CT, GA, MA, NY, PA, VA, and WI.
Initiated: Voluntary: Firm initiated
Recall number: Z-0851-2019

Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571

Terminated Class II Medical devices

Recall started: 19 December 2018
Terminated: 28 April 2020
Reason: There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.
Distribution: Worldwide Distribution: US (nationwide) to of states: AL, AZ, CA, GA, HI, IL, IN, KY, LA, MI, MN, MO, NC, NJ, NY, OH, PA, RI, TN, TX, and UT; and countries of: Austria, Belgium, Canada, Denmark, France, Germany, Great Britain, Hungary, Iceland, Italy, Netherlands, Norway, Spain, and Switzerland.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0968-2019, Z-0967-2019

Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the a
Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the a

Terminated Class II Medical devices

Recall started: 31 May 2018
Terminated: 11 April 2019
Reason: This lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging from non-specific febrile reaction to life-threatening systemic inflammatory response syndrome (SIRS).
Distribution: One distributor in Indiana; product was not further distributed to end users.
Initiated: Voluntary: Firm initiated
Recall number: Z-2791-2018

VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavity of the brain for

Terminated Class II Medical devices

Recall started: 16 April 2018
Terminated: 27 June 2019
Reason: Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa.
Distribution: Worldwide Distribution - US Nationwide in the states of AZ, DE, FL, GA, ID, IL, KY, MI, MO, NH, NJ, PA, RI, TX, UT and the country of Peru
Initiated: Voluntary: Firm initiated
Recall number: Z-1521-2018

Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0; UDI: 10827002522647 and 10827002522524 Product Usage: The Advance¿ 35LP Low Profile PTA Balloo

Terminated Class II Medical devices

Recall started: 29 March 2018
Terminated: 9 April 2019
Reason: Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
Distribution: Distributed to accounts in 7 states: AL, CA, GA, NE, NV, NY, and TX. International distribution to Japan, Korea, and Taiwan.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1752-2018, Z-1755-2018, Z-1756-2018, Z-1754-2018, Z-1753-2018, Z-1751-2018

Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may
Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be
Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be
Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be
Connecting Tube - Female to Male Luer Lock, HPCT8.8-30-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be
Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be

Terminated Class II Medical devices

Recall started: 22 March 2018
Terminated: 13 May 2020
Reason: Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user.
Distribution: Worldwide Distribution -- USA, Argentina, Bolivia, Brazil, Canada, Colombia, Guatemala, Mexico, Panama, Peru, Uruguay, and Venezuela.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1461-2018, Z-1460-2018

Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body fluids and cells, in particular oocyte aspiration.
Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intended for the aspiration of body fluids and cells; in particular oocyte aspiration.

Terminated Class II Medical devices

Recall started: 31 January 2018
Terminated: 17 April 2020
Reason: The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
Distribution: US Nationwide, OUS countries: AE, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DJ, DK, DO, EC, EE, EG, ES, FI, FJ, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IT, JO, KZ, LB, LT, LV, MA, MO, MX, MY, NI, NL, NO, NZ, PE, PH, PK, PL, PR, PT, QA, RO, RU, SA, SE, SG, SI, SK, SV, TH, TT, TW, U
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1591-2018, Z-1596-2018, Z-1594-2018, Z-1590-2018, Z-1595-2018, Z-1593-2018, Z-1592-2018

StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993
StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-016500; SBP-016605; SBP-020425 GPN : G52607; G52605; G52606; G52609; G52608
StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044
StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034
StoneBreaker Probe Cap, Catalog number:SBA-PC; GPN: G52601; UDI:(01)00827002526013
StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006

Terminated Class II Medical devices

Recall started: 12 January 2018
Terminated: 8 May 2020
Reason: The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater.
Distribution: Nationwide (K-IMNC-100 -US G46022) . (K-IMNC-100 G20079 manufactured in Australia and distributed worldwide)
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1378-2018, Z-1377-2018

MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.
MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.

Terminated Class II Medical devices

Recall started: 19 December 2017
Terminated: 9 April 2019
Reason: Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and/or nonviable embryos.
Distribution: Worldwide Distribution - U.S. Nationwide in the states of: CA, CO, FL, IN, MA, NE, NJ, OH, TN, TX, and WI. and countries of Belarus, Belgium, Brazil, Canada, Chile, China, Egypt, Italy, Japan, Poland, Saudi Arabia, Spain, and United Kingdom.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1185-2018, Z-1186-2018, Z-1188-2018, Z-1187-2018

Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900, Global Product Number: G17946 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for
1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24215; 3. Sydney IVF¿
Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number: G18022 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use

Terminated Class II Medical devices

Recall started: 19 October 2017
Terminated: 16 April 2019
Reason: Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
Distribution: US Nationwide Distribution
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0830-2018, Z-0831-2018, Z-0832-2018

Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding

Terminated Class II Medical devices

Recall started: 13 October 2017
Terminated: 23 October 2019
Reason: Label does not state that the product is heparin-coated.
Distribution: Nationally
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0954-2018, Z-0959-2018, Z-0948-2018, Z-0950-2018, Z-0951-2018, Z-0966-2018, Z-0961-2018, Z-0949-2018, Z-0956-2018, Z-0965-2018, Z-0953-2018, Z-0947-2018 and 8 more

Coons Interventional Wire Guide
Movable Core Wire Guide
Amplatz Extra Stiff Wire Guide
Amplatz Ultra Stiff Wire Guide
Bentson Cerebral Wire Guide
Femoral Artery Pressure Monitoring Set
Reuter Tip Deflecting Wire Guide
Amplatz Stiff Wire Guide
and 12 more product lines

Terminated Class II Medical devices

Recall started: 31 July 2017
Terminated: 8 May 2019
Reason: Central venous catheters may not fit over guide wire potentially causing procedure delay.
Distribution: Worldwide distribution - US Nationwide in the states of: AL, CA, CO, FL, GA, IA, IL, KY, LA, MD, MI, MN, MO, NC, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI; the District of Columbia and the countries of Belgium, India Italy, Spain, and United Kingdom.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0633-2018, Z-0632-2018, Z-0630-2018, Z-0631-2018, Z-0634-2018

Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Co
Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog Identifiers: C-UTLM-501J-25-6.5-WCE-BH, C-UTLM-501J-BH Product Usage: The central venous catheter is designed for treatment of critically
Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-UTLM-501J Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuo
Central Venous Catheter Tray Triple Lumen Polyurethane, Catalog Identifier: C-UTLMYJ-501J Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Conti
Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Catalog Identifiers: C-UTLMY-501J-ABRM-HC-FST and C-UTLMY-501J-ABRM-HC-IHI-FST Usage: The Spectrum Central Venous Catheter is used fo

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.