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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Oct 21, 2021 Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I ... Aberrometer and precision laser systems are affected by a remote code execution vulnerability exi... Class II AMO Manufacturing USA, LLC
Oct 21, 2021 iDesign, Model - G300: System AWS (International), System AWS (China), Advanc... Aberrometer and precision laser systems are affected by a remote code execution vulnerability exi... Class II AMO Manufacturing USA, LLC
Sep 16, 2013 STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Produ... This corrective action will address an identified failure of the lamp and illumination system wit... Class II Abbott Medical Optics, Inc.
Sep 16, 2013 STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product... This corrective action will address an identified failure of the lamp and illumination system wit... Class II Abbott Medical Optics, Inc.
Sep 16, 2013 STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-24... This corrective action will address an identified failure of the lamp and illumination system wit... Class II Abbott Medical Optics, Inc.
Sep 16, 2013 STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalo... This corrective action will address an identified failure of the lamp and illumination system wit... Class II Abbott Medical Optics, Inc.
May 28, 2013 STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA... Under specific conditions, there is an unlikely potential to result in inadvertent laser firing o... Class II Abbott Medical Optics, Inc.
May 28, 2013 STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC ... Under specific conditions, there is an unlikely potential to result in inadvertent laser firing o... Class II Abbott Medical Optics, Inc.
May 28, 2013 STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO M... Under specific conditions, there is an unlikely potential to result in inadvertent laser firing o... Class II Abbott Medical Optics, 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.