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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
Sep 22, 2017 Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO Leaks complaints. Class II Guangzhou Improve Medical Instruments Co., Ltd.
Sep 22, 2017 Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Pr... Complain due to the hub needle came out when the nurse draw the blood and removed the tube. Class II Guangzhou Improve Medical Instruments Co., Ltd.
Oct 19, 2016 Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO ... Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the... Class II Guangzhou Improve Medical Instruments Co., Ltd.

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.