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Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

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DateProductReasonClassFirm
Sep 25, 2025 Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast ... Due to an identified manufacturing defect involving coating material lifting within the catheter'... Class I BALT USA, LLC
May 8, 2025 Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BL... Due to radiopaque (RO) marker was not visible during angiography and it was determined that the R... Class II BALT USA, LLC
May 8, 2025 Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1... Due to radiopaque (RO) marker was not visible during angiography and it was determined that the R... Class II BALT USA, LLC
Jan 3, 2024 The Prestige Coil System is a product family of embolic coils with associated... Discoloration was identified along the delivery pusher which was attributed to corrosion of the h... Class II BALT USA, LLC
Jan 3, 2024 Neurovascular embolization device. The Optima Coil System is a series special... Discoloration was identified along the delivery pusher which was attributed to corrosion of the h... Class II BALT USA, LLC
Sep 7, 2022 Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308... Product pouch label does not match up with carton label Class II BALT USA, LLC
Jul 26, 2022 Optima Coil System Model OPTI0520CSF10. For endovascular embolization. Products were released to customers prior to the approval and release of a test report authorizin... Class II BALT USA, LLC
Jan 4, 2022 The Optima Coil System consists of an implantable embolization coil comprised... Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch la... Class II BALT USA, 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.