Browse Device Recalls

3,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,276 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 3,276 FDA device recalls in 2024.

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DateProductReasonClassFirm
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 SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgi... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surg... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
Sep 20, 2024 SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties an... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
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 SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties an... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
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 SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties ... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
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 SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and sur... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
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 SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and su... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
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 SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and su... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
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 VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W... There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use. Class I Maquet Cardiovascular, LLC
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 SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and ... Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... Class II Integra LifeSciences Corp.
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.
Sep 19, 2024 Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386 The firm received customer reports stating that the batteries and their connectors experienced el... Class II Baxter Healthcare Corporation
Sep 19, 2024 AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (... Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified... Class II Ad-Tech Medical Instrument Corporation
Sep 19, 2024 Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048 The firm received customer reports stating that the batteries and their connectors experienced el... Class II Baxter Healthcare Corporation
Sep 19, 2024 NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - ... Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical markin... Class II Novosource, LLC
Sep 19, 2024 Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 160478... The firm received customer reports stating that the batteries and their connectors experienced el... Class II Baxter Healthcare Corporation
Sep 19, 2024 AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (... Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified... Class II Ad-Tech Medical Instrument Corporation
Sep 19, 2024 Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049 The firm received customer reports stating that the batteries and their connectors experienced el... Class II Baxter Healthcare Corporation
Sep 19, 2024 Baxter Operating Table TruSystem 7000, Product code REF 1841046 The firm received customer reports stating that the batteries and their connectors experienced el... Class II Baxter Healthcare Corporation
Sep 19, 2024 Baxter Operating Table TruSystem 7000 V, Product code REF 1841050 The firm received customer reports stating that the batteries and their connectors experienced el... Class II Baxter Healthcare Corporation
Sep 19, 2024 Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082 The firm received customer reports stating that the batteries and their connectors experienced el... Class II Baxter Healthcare Corporation
Sep 19, 2024 AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (... Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified... Class II Ad-Tech Medical Instrument Corporation
Sep 19, 2024 Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385 The firm received customer reports stating that the batteries and their connectors experienced el... Class II Baxter Healthcare Corporation
Sep 19, 2024 Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH0... Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure test... Class II Covidien LP
Sep 19, 2024 Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083 The firm received customer reports stating that the batteries and their connectors experienced el... Class II Baxter Healthcare Corporation
Sep 18, 2024 Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components... The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use. Class II Medtronic Neuromodulation
Sep 18, 2024 Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Na... To better define the drying procedures described in the IFU to improve the instructions for easie... Class II Olympus Corporation of the Americas
Sep 18, 2024 a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P... The beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System w... Class II Baxter Healthcare Corporation
Sep 18, 2024 A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-enc... The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge... Class II Polymer Technology Systems, Inc. dba PTS Diagno...
Sep 18, 2024 Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 8090... Due to oximeters not having FDA market approval or clearance to distribute in the U.S. Class II Nihon Kohden America Inc
Sep 18, 2024 Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in ... Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached... Class II American Surgical Company, LLC

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.