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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Aug 19, 2015 Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF... One Distal Access Catheter intended for distribution in Korea, was found at a US location. Class II Concentric Medical Inc
Jun 25, 2014 Merci Retriever Intended to restore blood flow in the neurovasculature by ... Merci Retrievers were shipped to US customers past their expiration date, even though they were l... Class II Concentric Medical Inc
Nov 13, 2013 Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: ... Product shipped to US customers had non U.S. Instruction for use with indication for Use that wer... Class II Concentric Medical Inc
Sep 26, 2013 Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Di... Distal Access Catheters were shipped to US customers with the Directions for Use that included in... Class II Concentric Medical Inc
Dec 20, 2012 FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountai... Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Ba... Class II Concentric 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.