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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
May 5, 2021 v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model... Due to a software error, the user may lose functionality of the system or the screen may turn bla... Class II Abbott Laboratories Inc. (St Jude Medical)
May 5, 2021 WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012 Due to a software error, the user may lose functionality of the system or the screen may turn bla... Class II Abbott Laboratories Inc. (St Jude Medical)
May 5, 2021 v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Displ... Due to a software error, the user may lose functionality of the system or the screen may turn bla... Class II Abbott Laboratories Inc. (St Jude Medical)
Apr 22, 2021 NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000 Potential capacitor failure which typically manifests as in inability to provide output on one or... Class II Abbott Laboratories Inc. (St Jude Medical)
Apr 5, 2019 TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 P... In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version ... Class II Abbott Laboratories Inc. (St Jude Medical)

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.