Toano, VA, United States
AVID Medical, Inc. recalls
25 recalls recorded since 2018, most recently on 10 August 2026. 21 are listed as ongoing. Status and classification are as published by the FDA.
Recalls25
Ongoing (FDA)21
Terminated or completed4
Class I (FDA)7
Ongoing Class I Medical devices
- Recall started
- 10 August 2026
- Reason
- Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
- Distribution
- Domestic: IL, NC, VA, WY;
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3151-2026, Z-3154-2026, Z-3153-2026, Z-3152-2026
- Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;
- Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;
- Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;
- Haylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05;
Ongoing Class II Medical devices
- Recall started
- 10 August 2026
- Reason
- Product may be potentially contaminated with a lubricant used during the manufacturing process.
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0098-2027, Z-0094-2027, Z-0096-2027, Z-0103-2027, Z-0092-2027, Z-0105-2027, Z-0106-2027, Z-0093-2027, Z-0104-2027, Z-0101-2027, Z-0095-2027, Z-0099-2027 and 3 more
- ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;
- ADULT HEART TRAY SHANDS JACKS; Model/Item Number (Kit): SHND419-08;
- CRANIOTOMY PACK; Model/Item Number (Kit): WRNM035-20;
- UROLOGY MAJOR; Model/Item Number (Kit): WRNM058-10;
- DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;
- GYN LAPAROSCOPY PACK; Model/Item Number (Kit): NAMC436-12;
- ABD HYSTERECTOMY; Model/Item Number (Kit): NAMC438-07;
- GYN LAPAROSCOPY/LAPAROTOMY; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH108-03;
- and 7 more product lines
Ongoing Class I Medical devices
- Recall started
- 22 July 2026
- Reason
- Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3194-2026
- Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.
Ongoing Class II Medical devices
- Recall started
- 22 July 2026
- Reason
- Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3260-2026, Z-3261-2026
- Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02
- Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-01
Ongoing Class I Medical devices
- Recall started
- 14 July 2026
- Reason
- Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides
- Distribution
- US Nationwide distribution in the state of NE.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3108-2026
- Halyard IV START KIT NON-STERILE REF: KRIV26-02
Ongoing Class II Medical devices
- Recall started
- 14 July 2026
- Reason
- Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area.
- Distribution
- US Nationwide distribution in the state of NE.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3109-2026
- Halyard IV Start Kit Non-Sterile REF: KRIV26-02
Ongoing Class II Medical devices
- Recall started
- 10 July 2026
- Reason
- The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
- Distribution
- US Nationwide distribution in the state of TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2964-2026
- Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
Ongoing Class II Medical devices
- Recall started
- 9 July 2026
- Reason
- Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
- Distribution
- US Nationwide distribution in the states of MS, TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3006-2026, Z-3005-2026, Z-3011-2026, Z-3009-2026, Z-3010-2026, Z-3008-2026, Z-3007-2026
- Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
- Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27
- Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
- Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
- Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
- Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
- Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Ongoing Class II Medical devices
- Recall started
- 19 May 2026
- Reason
- The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, WA, WY, TX, MI, FL, MD, UT, NC, MS, PA, MO, IA, NE, OH, IL, SD, MN, GA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3046-2026, Z-3044-2026, Z-3045-2026
- Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01; 2) POSTERIOR PACK - 205960, Model/Item Number (kit) ANPP15-01; 3) ANEURYSM PACK, Model/Item Number (kit) BPAY14
- Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT, Model/Item Number (kit) ACEN89-02; 3) BACK PACK, Model/Item Number (kit) ALBK51-01; 4) DR DERIAN SPINE PACK SNEDHCP
- 1) NEURO, (kit) ACNE73-01; 2) NEURO, (kit) ACNE73-03; 3) CRANI, (kit) AKCR19-01; 4) ORTHO SPINE PACK, (kit) ARMC017; 5) BMHM NEURO PACK, (kit) BMHT016-05; 6) LUMBAR PACK, (kit) BMHT112-03; 7) NEURO LAMINECTOM
Ongoing Class II Medical devices
- Recall started
- 19 May 2026
- Reason
- Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.
- Distribution
- U.S. Nationwide distribution in the state of California.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2772-2026
- Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
Ongoing Class II Medical devices
- Recall started
- 7 May 2026
- Reason
- Incorrect concentration of Betadine solution contained within certain AVID convenience kits.
- Distribution
- US Nationwide distribution in the state of California.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2763-2026
- Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.
Ongoing Class II Medical devices
- Recall started
- 30 April 2026
- Reason
- Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
- Distribution
- US Nationwide distribution in the state of Iowa.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2408-2026, Z-2407-2026, Z-2409-2026, Z-2410-2026
- Halyard, Towel Six Pack. Kit Code: AMTS70-01.
- Halyard, Pain Pack. Kit Code: AMPK48-01.
- Halyard, Drape Pack. Kit Code: LMDP36-01.
- Halyard, Eye Bag Pack. Kit Code: UIEB48-01.
Ongoing Class I Medical devices
- Recall started
- 30 April 2026
- Reason
- Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
- Distribution
- US Nationwide distribution in the states of NC and TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2797-2026, Z-2796-2026, Z-2798-2026
- Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15
- Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05
- Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05
Ongoing Class I Medical devices
- Recall started
- 13 March 2026
- Reason
- Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- Distribution
- US distribution to FL, IL, MO, MS, NC, NE, TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1972-2026, Z-1971-2026, Z-1979-2026, Z-1974-2026, Z-1970-2026, Z-1973-2026, Z-1976-2026, Z-1975-2026, Z-1978-2026, Z-1977-2026
- Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
- Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.
- Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.
- Halyard CATH LAB kit. Model Number: SACL75-01.
- Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
- Halyard CATH LAB kit. Model Number: SACL75AM.
- Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.
- Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
- and 2 more product lines
Ongoing Class II Medical devices
- Recall started
- 2 January 2026
- Reason
- Tyvek bag seal issue which may compromise sterility of the kit.
- Distribution
- US Nationwide distribution in the states of New Jersey.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1338-2026
- Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Ongoing Class II Medical devices
- Recall started
- 14 November 2025
- Reason
- Potential for incomplete seal on header bag.
- Distribution
- US distribution to GA, IL, NE, MD.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0928-2026, Z-0927-2026, Z-0929-2026, Z-0930-2026, Z-0926-2026
- Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.
- Halyard, EP LAB PK. Catalog Number: ESJH009-03.
- Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.
- Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.
- Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.
Ongoing Class I Medical devices
- Recall started
- 11 November 2025
- Reason
- Devices are not suitable for organ transplant.
- Distribution
- US Nationwide distribution in the states of FL, GA and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1001-2026, Z-1000-2026, Z-1002-2026
- Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
- Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
- Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Ongoing Class II Medical devices
- Recall started
- 4 August 2025
- Reason
- Potential for open header bag seals, compromising sterility.
- Distribution
- US Nationwide distribution in the state of Florida.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2530-2025, Z-2531-2025
- Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
- Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.
Ongoing Class II Medical devices
- Recall started
- 11 June 2025
- Reason
- CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
- Distribution
- Domestic: CA, IL, MD, OH, PA, TX, WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2251-2025, Z-2253-2025, Z-2259-2025, Z-2257-2025, Z-2255-2025, Z-2244-2025, Z-2260-2025, Z-2254-2025, Z-2240-2025, Z-2263-2025, Z-2250-2025, Z-2262-2025 and 12 more
- GYN ROBOTIC PACK. Medical convenience kit.
- LAP CHOLE PACK. Medical convenience kit.
- PACK GENERAL ROBOTIC. Medical convenience kit.
- LAVH PACK. Medical convenience kit.
- LAPAROSCOPIC PROSTATECTOMY. Medical convenience kit.
- DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.
- PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit.
- LAPAROSCOPIC GYN. Medical convenience kit.
- and 16 more product lines
Ongoing Class II Medical devices
- Recall started
- 31 March 2025
- Reason
- An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
- Distribution
- US Nationwide distribution in the states of IL & LA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1741-2025, Z-1743-2025, Z-1742-2025
- Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
- Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.
- Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
Ongoing Class II Medical devices
- Recall started
- 20 September 2024
- Reason
- Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0391-2025, Z-0413-2025, Z-0392-2025, Z-0385-2025, Z-0390-2025, Z-0454-2025, Z-0394-2025, Z-0433-2025, Z-0427-2025, Z-0387-2025, Z-0448-2025, Z-0420-2025 and 61 more
- Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06
- Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08
- Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03
- Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02
- Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07
- Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02
- Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05
- Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07
- and 65 more product lines
Terminated Class I Medical devices
- Recall started
- 9 April 2021
- Terminated
- 18 July 2022
- Reason
- Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.
- Distribution
- Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1785-2021, Z-1787-2021, Z-1784-2021, Z-1786-2021
- FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
- DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.
- ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04
- FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
Terminated Class II Medical devices
- Recall started
- 18 February 2020
- Terminated
- 23 November 2020
- Reason
- The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.
- Distribution
- US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1517-2020, Z-1521-2020, Z-1523-2020, Z-1518-2020, Z-1515-2020, Z-1522-2020, Z-1520-2020, Z-1519-2020, Z-1516-2020
- Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
- Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
- Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
- Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
- Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
- Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
- Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
- Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
- and 1 more product lines
Terminated Class II Medical devices
- Recall started
- 3 July 2017
- Terminated
- 17 April 2018
- Reason
- The swab stick collection device provided in a convenience kit expires prior to the kit expiration date.
- Distribution
- Seventeen sites located in 13 states: FL, IN, KS, KY, MA, OK, NC, NE, NY, OH, PA, VA, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0581-2018
- AVID Medical QA Pack AV10654-10
Terminated Class II Medical devices
- Recall started
- 22 June 2017
- Terminated
- 12 October 2018
- Reason
- Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- Distribution
- Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0780-2018, Z-0791-2018, Z-0789-2018, Z-0800-2018, Z-0794-2018, Z-0795-2018, Z-0788-2018, Z-0782-2018, Z-0798-2018, Z-0796-2018, Z-0785-2018, Z-0786-2018 and 11 more
- AVID TruCustom DAVINCI PACK convenience kits, Item Code: ADVU037-09
- AVID TruCustom KNEE ARTHROSCOPY PACK convenience kits, Item Code: MADN011-02
- AVID TruCustom GENERAL PACK convenience kits, Item Code: LGHM041-06 and LGHM041-08
- AVID TruCustom SHOULDER ARTHROSCOPY convenience kits, Item Code: MADN010-02
- AVID TruCustom MINOR PROCEDURE 6A convenience kits, Item Code: MADN032-01
- AVID TruCustom NEURO PK convenience kits, Item Code: LGHM021-08
- AVID TruCustom EXTREMITY PACK convenience kits, Item Code: MADN012-01 and MADN012-02
- AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04
- and 15 more product lines
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.