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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

180 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 180 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 180 FDA device recalls.

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DateProductReasonClassFirm
Sep 20, 2024 Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard PACK, MINOR - Medical convenience kits Model Number: VMED018-02 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN01... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ00... 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: EUOR002-06 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard SHOULDER PACK - Medical convenience kits Model Number: PANJ005 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard POST PARTUM TUBAL LIGATION - Medical convenience kits Model Number: ... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits Model Number: ... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN4... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVM... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard RAD PACK - Medical convenience kits Model Number: VANW017-04 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05 Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
Sep 20, 2024 Halyard UPPER EXTREMITY PACK - Medical convenience kits Model Number: PANJ00... Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach... Class II AVID Medical, Inc.
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.

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.