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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

Clear
DateProductReasonClassFirm
Jul 18, 2018 Sedecal NOVA FA DR System. for diagnostic radiography. A safety problem with installation and maintenance could lead to the breakage of the two steel ca... Class II Sedecal S.A.
Jan 18, 2016 Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by ... This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x... Class II Sedecal S.A.
Jul 13, 2015 RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Inte... Electrostatic energy may be stored in Systems that can cause a short-cicuit which, in turn, can g... Class II Sedecal S.A.
Aug 6, 2014 MobileDiagnost wDR motorized portable diagnostic X-ray systems. Reports of unexpected movement. Class II Sedecal S.A.

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.