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Browse Device Recalls

14 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 14 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 14 FDA device recalls.

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DateProductReasonClassFirm
Feb 23, 2017 Ziehm Imaging solo FD Mobile Fluoroscopic C-arm During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel wa... Class II Ziehm Imaging Inc
Apr 15, 2016 Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute time... Class II Ziehm Imaging Inc
Apr 15, 2016 Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute time... Class II Ziehm Imaging Inc
Apr 15, 2016 Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute time... Class II Ziehm Imaging Inc
Apr 15, 2016 Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute time... Class II Ziehm Imaging Inc
Apr 15, 2016 Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute time... Class II Ziehm Imaging Inc
Apr 15, 2016 Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute time... Class II Ziehm Imaging Inc
Nov 21, 2013 Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fl... Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the ... Class II Ziehm Imaging Inc
Nov 21, 2013 Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Flu... Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the ... Class II Ziehm Imaging Inc
Nov 21, 2013 Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoro... Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the ... Class II Ziehm Imaging Inc
Nov 21, 2013 Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile ... Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the ... Class II Ziehm Imaging Inc
Nov 21, 2013 Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluorosc... Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the ... Class II Ziehm Imaging Inc
Nov 21, 2013 Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mob... Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the ... Class II Ziehm Imaging Inc
Nov 21, 2013 Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Flu... Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the ... Class II Ziehm Imaging 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.