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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
Oct 16, 2020 DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a cha... Due to footswitch not meeting required specification for protection from ingress of solids or liq... Class II Ra Medical Systems, Inc.
Jul 24, 2020 DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intend... Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user o... Class II Ra Medical Systems, Inc.
Jan 23, 2020 DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an ... A software issue was identified which could result in user or patient injury, or may adversely im... Class II Ra Medical Systems, Inc.
Sep 19, 2019 Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-0904... The firm has become aware there is a potential problem with its DABRA catheters resulting in high... Class II Ra Medical Systems, Inc.
Aug 23, 2019 Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excime... At doses of less than 100 mJ, in custom and auto repeat modes, a software error in the excimer la... Class II Ra Medical Systems, Inc.

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.