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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Sep 10, 2019 A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fractur... Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding d... Class II Alto Development Corp
Sep 10, 2019 A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fractur... Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding d... Class II Alto Development Corp
Sep 10, 2019 A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture ... Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding d... Class II Alto Development Corp
Sep 10, 2019 A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture ... Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding d... Class II Alto Development Corp
Sep 10, 2019 A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture ... Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding d... Class II Alto Development Corp
Jun 21, 2019 A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped... Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Se... Class II Alto Development Corp
Oct 23, 2017 Surgical punch; sealed pouches packed in punch shelf box Intended for use... Surgical punches are being recalled due to potential packaging damage which may have occurred dur... Class II Alto Development Corp

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.