Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Nov 24, 2014 Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number... Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in... Class II Arthrosurface, Inc.
Nov 24, 2014 Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: ... Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in... Class II Arthrosurface, Inc.
Nov 24, 2014 Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8... Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in... Class II Arthrosurface, Inc.
Nov 24, 2014 Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Num... Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in... Class II Arthrosurface, Inc.
Nov 24, 2014 Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number... Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in... Class II Arthrosurface, Inc.
Jun 9, 2014 Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal ... An oversight in the implementation of the design change record resulted in outdated components be... Class II Arthrosurface, 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.