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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
Mar 8, 2024 Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used f... Their is the potential for distal tip separation at the proximal marker band of the delivery cath... Class I ROUTE 92 MEDICAL INC
Mar 8, 2024 Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. ... Their is the potential for distal tip separation at the proximal marker band of the delivery cath... Class I ROUTE 92 MEDICAL INC
Mar 8, 2024 Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, Ster... Their is the potential for distal tip separation at the proximal marker band of the delivery cath... Class I ROUTE 92 MEDICAL INC
Mar 8, 2024 Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO.... Their is the potential for distal tip separation at the proximal marker band of the delivery cath... Class I ROUTE 92 MEDICAL INC
Mar 8, 2024 Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for... Their is the potential for distal tip separation at the proximal marker band of the delivery cath... Class I ROUTE 92 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.