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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
Oct 14, 2021 IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I Lumenis, Inc.
Aug 15, 2014 Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser... Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) becau... Class II Lumenis, Inc.
Aug 19, 2013 Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. ... Lumenis has initiated a recall on certain models of Vision One System due to a potential for unin... Class II Lumenis, 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.