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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

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DateProductReasonClassFirm
Mar 14, 2024 Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Tes... Due to a manufacturing variation of the irrigation sleeves which could result in a missing port h... Class II Johnson & Johnson Surgical Vision, Inc.
Dec 12, 2023 TECNIS Toric II OptiBlue IOL Models ZCW Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks ... Class II Johnson & Johnson Surgical Vision, Inc.
Jul 6, 2023 TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fidu... Class II Johnson & Johnson Surgical Vision, Inc.
Jul 6, 2023 TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fidu... Class II Johnson & Johnson Surgical Vision, Inc.
May 30, 2023 VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs ... Weld protrusion/physical gap between the housing and pack cover, may exceed design specification,... Class II Johnson & Johnson Surgical Vision, Inc.
Dec 7, 2022 Single-Use Packs, REF: OPO80 Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specific... Class II Johnson & Johnson Surgical Vision, Inc.
Dec 7, 2022 Veritas Advanced Infusion Packs, REF: VRT-AI Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specific... Class II Johnson & Johnson Surgical Vision, Inc.
Dec 7, 2022 FUSION Dual Pump Packs, REF: OPO73 Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specific... Class II Johnson & Johnson Surgical Vision, Inc.
Sep 7, 2022 THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S... Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irr... Class II Johnson & Johnson Surgical Vision, Inc.
Sep 1, 2022 Veritas Advanced Infusion Packs. Used in ophthalmic procedures. As a result of returned product complaints for Veritas Phaco packs related to broken or cracked i... 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.