Browse Device Recalls

905 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 905 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 905 FDA device recalls in 2026.

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DateProductReasonClassFirm
Jan 5, 2026 Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI... Due to a modification by a vendor and may be reinstalled without properly engaging the outside re... Class II Raz Design Inc
Jan 5, 2026 VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) ... Potential risk of Quality Control failures and/or false resistant antibiotic results when testing... Class II Biomerieux Inc
Jan 2, 2026 ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 26... Due a design issue where the navigated array connection geometry is incorrect. Class II Alphatec Spine, Inc.
Jan 2, 2026 ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 26... Due a design issue where the navigated array connection geometry is incorrect. Class II Alphatec Spine, Inc.
Jan 2, 2026 Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01. Tyvek bag seal issue which may compromise sterility of the kit. 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.