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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
Sep 20, 2014 Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. ... TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be... Class I Trivascular, Inc
Feb 27, 2014 Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc.... Communication to European physician users of the Ovation Prime Abdominal Stent Graft system to no... Class II Trivascular, Inc
Oct 19, 2012 TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment Sy... Selected lots of the Fill Polymer Kit (European Model Number: TVFP14- B) in European distributor... Class II Trivascular, 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.