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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Jul 12, 2023 CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K Incorrect Laser Marking - Solera Awl Tip Tap Class II Medtronic Sofamor Danek USA, Inc
Apr 27, 2021 Braive Growth Modulation System Break-Off Set Screws - Product Usage: intende... Product is impacted by a thread profile defect due to a manufacturing issue. Class II Medtronic Sofamor Danek USA, Inc
Mar 17, 2021 Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 De... The shelf box identifies a small device actually contains a large device, and the shelf box ident... Class II Medtronic Sofamor Danek USA, Inc
Mar 17, 2021 Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 De... The shelf box identifies a small device actually contains a large device, and the shelf box ident... Class II Medtronic Sofamor Danek USA, Inc
May 13, 2016 Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number:... Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a pot... Class II Medtronic Sofamor Danek Usa, Inc - Dallas Distr...
Apr 8, 2016 Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for u... Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecti... Class II Medtronic Sofamor Danek Usa, Inc - Dallas Distr...
Oct 21, 2015 Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used... The wire pass hole is not present on the tools. Class II Medtronic Sofamor Danek Usa, Inc - Dallas Distr...

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.