Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 FDA device recalls.

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DateProductReasonClassFirm
May 2, 2015 Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and prod... Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch du... Class I Synovis Surgical Innovations, Inc.
Oct 28, 2013 Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura sub... Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD ... Class II Synovis Surgical Innovations, Inc.
Oct 28, 2013 Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in pe... Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD ... Class II Synovis Surgical Innovations, 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.