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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Apr 12, 2017 Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxi... The manufacturer of the DOLPHIN inflation device, Perouse Medical, has initiated a recall of the ... Class II Vascular Solutions, Inc.
Apr 5, 2017 DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 01... Complaints regarding broken blister. Class II PEROUSE MEDICAL
Oct 6, 2014 Synthes Inflation System (03.804.4135) Product Usage: Inflation system i... Additional instructions for use due to inability to raise the pressure above 10 atm during inflat... Class II PEROUSE MEDICAL
Oct 6, 2014 Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device i... Additional instructions for use due to inability to raise the pressure above 10 atm during inflat... Class II PEROUSE MEDICAL
May 10, 2012 Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascu... Perouse Medical in France initiated a voluntary recall of certain batches of Perouse FLAMINGO Inf... Class II Perouse Medical

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.