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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

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DateProductReasonClassFirm
Aug 8, 2024 Ziehm Vision FD. Interventional fluoroscopic x-ray system Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that ins... Class II Orthoscan, Inc.
Aug 8, 2024 Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that ins... Class II Orthoscan, Inc.
Aug 8, 2024 Ziehm Vision R. Iterventional fluoroscopic x-ray system Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that ins... Class II Orthoscan, Inc.
Aug 8, 2024 Ziehm Vision system, x-ray, tomography, computed. Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that ins... Class II Orthoscan, Inc.
Aug 8, 2024 Ziehm Vision RFD. Interventional fluoroscopic x-ray system Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that ins... Class II Orthoscan, Inc.
Aug 8, 2024 Ziehm Solo FD. Interventional fluoroscopic x-ray system Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that ins... Class II Orthoscan, Inc.
Aug 8, 2024 Ziehm Solo. Digital Mobile C-arm Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that ins... Class II Orthoscan, Inc.
Aug 31, 2017 Mobile Mini C-arm system Part # 1000-0005. Intended to provide the physic... OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of th... Class II Orthoscan, Inc.
Aug 31, 2017 Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physic... OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of th... Class II Orthoscan, Inc.
Aug 31, 2017 Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the phys... OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of th... Class II Orthoscan, Inc.
Aug 31, 2017 Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physic... OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of th... Class II Orthoscan, 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.