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
Aug 23, 2024 BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net con... The bulk product used in the recalling firm's repackaged finished product was recalled due to bac... Class II Young Dental Manufacturing I, LLC
May 13, 2024 Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032 Class II Young Dental Manufacturing I, LLC
Oct 6, 2023 CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite... Class II Young Dental Manufacturing I, LLC
May 23, 2023 BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varni... Class II Young Dental Manufacturing I, LLC
Dec 5, 2022 Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714 mislabeled product Class III Young Dental Manufacturing I, LLC

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.