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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.

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DateProductReasonClassFirm
May 3, 2018 ProCair Mattress: (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 (b) PROC... Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattr... Class II Joerns Healthcare
May 3, 2018 P.R.O. Matt: (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP36... Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattr... Class II Joerns Healthcare
Sep 24, 2014 Joerns EasyCare Bed Product Usage: The AC-powered adjustable hospital bed... The Easy-Care Care-Lock feature installed at the foot of the bed may potentially fail to stay eng... Class II Joerns Healthcare
Dec 13, 2012 SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patien... SR Instruments Inc. is implementing a field correction for the Joerns Healthcare Patient Lifts af... Class II Sr Instruments 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.