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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
Jan 25, 2024 IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) ... Due to an error in the manufacturing process, it is possible that an incorrect plunger has been f... Class II Voco GmbH
Jan 25, 2024 Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, ... Due to an error in the manufacturing process, it is possible that an incorrect plunger has been f... Class II Voco GmbH
Jul 9, 2019 Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invas... The metal cannula are potentially too loose and may become loose when applying the filing material. Class II Voco GmbH
Nov 3, 2016 VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M... Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Univ... Class II Voco GmbH

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.