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Browse Device Recalls

12 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 12 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 12 FDA device recalls.

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DateProductReasonClassFirm
Aug 22, 2025 Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breath... One lot manufactured with an invalid sterilization cycle. Class II CooperVision, Inc.
Aug 22, 2025 Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant... One lot manufactured with an invalid sterilization cycle. Class II CooperVision, Inc.
Aug 22, 2025 MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. ... One lot manufactured with an invalid sterilization cycle. Class II CooperVision, Inc.
Jun 16, 2025 Biofinity Toric Multifocal Contact Lens Lens blisters may have an incomplete or leaking seal which may render them unsterile. Class II CooperVision, Inc.
Jun 16, 2025 Biofinity XR Toric Contact Lens Lens blisters may have an incomplete or leaking seal which may render them unsterile. Class II CooperVision, Inc.
Feb 27, 2025 Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Conta... a limited number of lots were manufactured with an incorrect cylinder power. Class II CooperVision, Inc.
Aug 29, 2024 BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction ... Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience ... Class II CooperVision, Inc.
Aug 29, 2024 Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the cor... Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience ... Class II CooperVision, Inc.
Feb 14, 2023 Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90 The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses ... Class II CooperVision, Inc.
Jan 26, 2023 Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (e... Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experi... Class II CooperVision, Inc.
Jan 26, 2023 Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear) Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experi... Class II CooperVision, Inc.
Dec 27, 2022 MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Con... Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor vis... Class II CooperVision, 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.