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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
Jun 6, 2025 Akreos, SKU: AO60P0300. Akreos intraocular lenses An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 ... Class III Bausch & Lomb Surgical, Inc.
Mar 27, 2025 Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVist... In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjun... Class I Bausch & Lomb Surgical, Inc.
Mar 27, 2025 Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Env... In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjun... Class I Bausch & Lomb Surgical, Inc.
Nov 7, 2020 MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric ... Product may be missing toric axis marks. Class II Bausch & Lomb Surgical, Inc.
Jun 9, 2020 enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb... The toric axis marks were misaligned (from the expected position in relation to the haptics) on a... Class II Bausch & Lomb Surgical, Inc.
Nov 5, 2018 enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for... Cosmetic imperfections on the surface of some lenses. Class II Bausch & Lomb Surgical, Inc.
Apr 5, 2017 SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the foldi... Complaints concerning kinked haptics that were occurring during lens delivery. Class II Bausch & Lomb Surgical, Inc.
May 26, 2015 Bausch & Lomb SofPort Advanced Optics Aspheric Lens Haptics breaking during lens loading and insertion. Class II Bausch & Lomb Surgical, Inc.
May 26, 2015 Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofP... Haptics breaking during lens loading and insertion. Class II Bausch & Lomb Surgical, Inc.
Oct 16, 2013 Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for p... Lens was manufactured with incorrect raw material. Class II Bausch & Lomb Surgical, 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.