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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Contact Lenses & Vision

Biofinity XR and Multifocal Contact Lenses Recalled for Sterility Risk

Agency Publication Date: July 23, 2025
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Summary

CooperVision, Inc. is recalling 1,224 units of Biofinity XR Toric and Biofinity Toric Multifocal contact lenses. The individual lens blister packs may have an incomplete or leaking seal, which can make the lenses unsterile and unsafe to wear. Affected lenses were distributed globally, including throughout the United States, between June and July 2025.

Risk

If a contact lens package is not properly sealed, the lens can be exposed to bacteria or other contaminants. Using an unsterile contact lens significantly increases the risk of serious eye infections, irritation, and potential vision loss.

What You Should Do

  1. This recall affects Biofinity XR Toric and Biofinity Toric Multifocal contact lenses sold in individual blister packs or multi-pack cartons.
  2. Check the carton lot number printed on your contact lens packaging. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled contact lenses immediately to avoid the risk of eye infection.
  4. Stop using the product. Return it to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or CooperVision, Inc. for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider, or return the product to the place of purchase for a refund or replacement
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Stop using and throw the product away.

Affected Products

Product: Biofinity XR Toric Contact Lens
Variants: XR Toric
Lot Numbers (78):
RD0226792
RD0227007
RD0227022
RD0227030
RD0227032
RD0228123
RD0228336
RD0228465
RD0228570
RD0228595
RD0228598
RD0228603
RD0228606
RD0228607
RD0228775
RD0228778
RD0228788
RD0228795
RD0228798
RD0228799
RD0228802
RD0228809
RD0228814
RD0228825
RD0228835
RD0228840
RD0228842
RD0228847
RD0228853
RD0228854
RD0228855
RD0228866
RD0228875
RD0228876
RD0228940
RE0152731
RE0152735
RE0152737
RE0152740
RE0152743
RE0152744
RE0152755
RE0152760
RE0152775
RE0152799
RE0152838
RE0152871
RE0152873
RE0152877
RE0152883

Quantity: 397 units

Product: Biofinity Toric Multifocal Contact Lens
Variants: Toric Multifocal
Lot Numbers (78):
RB0682365
RB0684301
RB0684305
RB0684311
RB0684313
RB0684317
RB0684321
RB0684325
RB0684335
RB0684506
RB0684575
RB0684582
RB0684653
RB0684657
RB0684659
RB0684663
RB0684664
RB0684667
RB0684668
RB0684669
RB0684670
RB0684673
RB0684674
RB0684676
RB0684682
RB0686359
RB0687092
RB0687368
RB0687370
RB0687547
RB0687582
RB0687586
RB0687665
RB0687693
RB0687797
RB0687800
RB0687801
RB0687802
RB0687803
RB0687807
RB0687812
RB0687822
RB0687893
RB0687897
RB0687904
RB0687908
RB0687910
RB0687922
RB0688105
RB0688107

Quantity: 827 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97173
Status: Active
Manufacturer: CooperVision, Inc.
Sold By: Eye care professionals; Optical retailers; Authorized vision distributors
Manufactured In: United States
Units Affected: 2 products (397 units; 827 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.