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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Apr 27, 2021 Quanta System Sterile Optical Laser Fiber, single use Product sterility is potentially compromised. Class II Quanta System, S.p.A.
Apr 27, 2021 Olympus Sterile Optical Laser Fiber, single use and reusable Product sterility is potentially compromised. Class II Quanta System, S.p.A.
Apr 27, 2021 Quanta System Sterile Optical Laser Fiber, reusable Product sterility is potentially compromised. Class II Quanta System, S.p.A.
Nov 7, 2012 Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Trea... Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional... Class II Quanta System, S.p.A.
Nov 7, 2012 Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument... Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional... Class II Quanta System, S.p.A.
Nov 7, 2012 Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hai... Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional... Class II Quanta System, S.p.A.

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.