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Browse Device Recalls

153 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 153 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 153 FDA device recalls.

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DateProductReasonClassFirm
Sep 20, 2024 Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH00... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM04... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH01... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Apr 9, 2021 FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part ... Medical convenience kits are being recalled due to a potential breach in the package integrity of... Class I Avid Medical, Inc.
Apr 9, 2021 ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAK... Medical convenience kits are being recalled due to a potential breach in the package integrity of... Class I Avid Medical, Inc.
Apr 9, 2021 DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03. Medical convenience kits are being recalled due to a potential breach in the package integrity of... Class I Avid Medical, Inc.
Apr 9, 2021 FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020. Medical convenience kits are being recalled due to a potential breach in the package integrity of... Class I Avid Medical, Inc.
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Feb 18, 2020 Custom procedure trays containing medical components needed to facilitate pat... The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufact... Class II Avid Medical, Inc.
Jul 3, 2017 AVID Medical QA Pack AV10654-10 The swab stick collection device provided in a convenience kit expires prior to the kit expiratio... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom PV MINOR PACK convenience kits, Item Code: MADN017-02 and MADN... Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom PACEMAKER TRAY convenience kits, Item Code: LAKC020-08 and LAK... Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom ELECTRO PHYSIOLOGY PK convenience kits, Item Code: LGHM033-04 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom LAMINECTOMY PACK convenience kits, Item Code: MADN013-02 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom DJ'S VASCULAR/NEURO TRAY convenience kits, Item Code: AV010930-12 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom UPPER EXTREMITY convenience kits, Item Code: LGHM050-03 and LG... Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom SPINE convenience kits, Item Code: LITT016-04 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom GYN LAPAROSCOPY convenience kits, Item Code: LGHM013-06 and LG... Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom HEART CATH TRAY convenience kits, Item Code: LAKC022-06 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom LOWER EXTREMITY convenience kits, Item Code: LGHM038-03 and LG... Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom PACEMAKER PACK (CARDIOLOGY) convenience kits, Item Code: VAMK016 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom CATH PACK convenience kits, Item Code: LGHM036-14 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom ORTHO TRAY convenience kits, Item Code: LGHM004-07 and LGHM004-08 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom PACEMAKER PACK convenience kits, Item Code: LGHM030-06 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom PLASTIC BASIN PACK convenience kits, Item Code: MADN008-03 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom EXTREMITY PACK convenience kits, Item Code: MADN012-01 and MAD... Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom NEURO PK convenience kits, Item Code: LGHM021-08 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom MINOR PROCEDURE 6A convenience kits, Item Code: MADN032-01 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom SHOULDER ARTHROSCOPY convenience kits, Item Code: MADN010-02 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom GENERAL PACK convenience kits, Item Code: LGHM041-06 and LGHM0... Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom KNEE ARTHROSCOPY PACK convenience kits, Item Code: MADN011-02 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Jun 22, 2017 AVID TruCustom DAVINCI PACK convenience kits, Item Code: ADVU037-09 Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles t... Class II Avid Medical, Inc.
Mar 15, 2017 Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hemat... Avid Medical Inc has received a complaint was received from an end-user indicating the vacutainer... Class II Avid Medical, Inc.
Oct 5, 2015 MAMMOGRAPHY Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) ... Class II Avid Medical, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.