Browse Device Recalls
1,708 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,708 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 1,708 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 30, 2012 | PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 E... | Lines on the screw gauge may not placed on the caddy properly which could result in improper meas... | Class II | Medtronic Sofamor Danek USA Inc |
| Aug 30, 2012 | ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-... | Lines on the screw gauge may not placed on the caddy properly which could result in improper meas... | Class II | Medtronic Sofamor Danek USA Inc |
| Jul 11, 2012 | Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-0... | A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat an... | Class II | Medtronic Navigation, Inc. |
| Oct 12, 2010 | Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: ... | Software Version 3.1.1 does not meet navigational accuracy. | Class II | Medtronic Navigation, Inc. |
| Sep 27, 2010 | Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 ... | In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtroni... | Class II | Medtronic Xomed, Inc. |
| Sep 27, 2010 | Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 ... | In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtroni... | Class II | Medtronic Xomed, Inc. |
| Sep 27, 2010 | Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 ... | In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtroni... | Class II | Medtronic Xomed, Inc. |
| Mar 4, 2009 | lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014... | Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the ... | Class II | Invatec Llc |
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.