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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Apr 6, 2022 TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only, Potential breach in the sterility barrier for tray ring covers. Class II Johnson & Johnson Surgical Vision Inc
Aug 6, 2021 TECNIS Eyhance IOLs are permanent intraocular implants intended for implantat... Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels h... Class II Johnson & Johnson Surgical Vision Inc
Jan 27, 2021 TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product ... Due to the release of nonconforming Intraocular Lenses (IOLs). Class II Johnson & Johnson Surgical Vision Inc
Dec 3, 2019 Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, ... Ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased pos... Class II Johnson & Johnson Surgical Vision Inc
Sep 24, 2018 Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optic... Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutt... Class II Johnson & Johnson Surgical Vision Inc
Jun 21, 2018 Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Del... Expired intraocular lenses were distributed. Class II Johnson & Johnson Surgical Vision Inc
May 9, 2018 OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.... Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specificall... Class II Johnson & Johnson Surgical Vision 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.