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Browse Device Recalls

112 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 112 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 112 FDA device recalls.

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DateProductReasonClassFirm
Apr 24, 2014 MOUSE 9732721 STERILE O-ARM 10PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 ENT PRGM 9734636 ADD FUSION NAV AxiEM Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 KIT, 9731427, THORACIC TACTILE PROBES Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 TUMOR RES. PACK 9733553 AxiEM S.M. Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 DRAPE 9732722 TUBE STERILE O-ARM 20PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 UPGRD PRGM 9734638 ADD AxiEM NAVIGATION Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Jul 25, 2013 Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 a... Review of on-system electronic product labeling and Instructions for comply with applicable Use i... Class II Medtronic Navigation, Inc.
Jul 15, 2013 StealthStation S7 Framelink Software version 5.4. Aid for locating anatom... Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5... Class II Medtronic Navigation, Inc.
Jan 31, 2013 Medtronic O-arm Imaging System Product Usage: image-intensified fluorosco... Potential failure of the braking system that controls the O-arm Imaging System gantry movement in... Class II Medtronic Navigation, Inc.
Nov 13, 2012 The Vertex Max Drill Tube is a component within the Navigated Vertex Max Dril... Medtronic is recalling certain Vertex Max Drill Tubes which are used with the StealthStation Syst... Class II Medtronic Navigation, 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.

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.