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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Aug 29, 2025 Getinge 88-Series Washer- Disinfector. Model Number: 88-5. Potential for device to overheat during operation if the circulation pressure calibration was not... Class II Getinge Disinfection Ab
Apr 2, 2025 Washer Disinfector Aquadis 56; Model Number: 56A The frequency inverter is not programmed by supplier according to specification which causes the ... Class II Getinge Disinfection Ab
Apr 2, 2025 Washer Disinfector Aquadis 56; Model Number: 56M The frequency inverter is not programmed by supplier according to specification which causes the ... Class II Getinge Disinfection Ab
Mar 2, 2018 Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI In... There is potential for a cart with disinfected goods to unload without the trolley being docked. ... Class II Getinge Disinfection Ab
Mar 2, 2018 Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI In... There is potential for a cart with disinfected goods to unload without the trolley being docked. ... Class II Getinge Disinfection Ab
Jun 26, 2015 Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8... Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated... Class III Getinge Disinfection Ab
Nov 26, 2014 GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS... Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the w... Class II Getinge Disinfection Ab
Jul 30, 2013 Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product U... Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series e... Class II Getinge Disinfection
May 25, 2012 Getinge brand --- large capacity, floor loading jet spray, washers for mechan... Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heate... Class II Getinge USA 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.