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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Dec 13, 2018 SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Produc... potential for urine leakage around the vent on the vented sample port Class II Bard Medical Division
Dec 6, 2018 BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing... Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 c... Class II Bard Medical Division
Jun 13, 2018 Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 500... An improper wiring connection on the chiller assembly may result in overheating of the connection... Class II Bard Medical Division
Apr 10, 2018 BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium ... Bard Medical Division is recalling the BARD¿ BrachySource¿ Iodine125 Radioactive Seeds in Mick¿ A... Class II Bard Brachytherapy, Inc.
Mar 21, 2018 Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Pro... Medline notified BMD that the Aplicare Povidone Iodine (PVP-I) Prep Pads were not meeting the iod... Class II Bard Medical Division
Nov 8, 2017 Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number ... Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesi... Class II Bard Medical Division

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.