--- title: "Biofinity XR Toric Contact Lens — FDA record Z-2165-2025 | Is It on Recall" description: "Lens blisters may have an incomplete or leaking seal which may render them unsterile." url: https://isitonrecall.com/recall/fda-device-z-2165-2025-biofinity-xr-toric-contact-lens/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Biofinity XR Toric Contact Lens — FDA record Z-2165-2025 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Jun 16, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Biofinity XR Toric Contact Lens - **Reason**: Lens blisters may have an incomplete or leaking seal which may render them unsterile. - **Classification**: Class II - **Recalling firm**: CooperVision, Inc. - **Quantity**: 397 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-2165-2025 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2165-2025%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Carton Lot Numbers: 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, RE0152889, RE0152891, RE0152913, RE0152915, RE0152917, RE0153804, RE0153819, RE0153924, RE0153974, RE0154076, RE0154085, RE0154095, RE0154100, RE0154103, RE0154105, RE0154107, RE0154113, RE0154114, RE0154117, RE0154137, RE0154139, RE0154143, RE0154253, RE0154256, RE0154259, RE0154264, RE0154271, RE0154329. | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Jul 30, 2025 - **Recall initiation date**: Jun 16, 2025 - **Center classification date**: Jul 23, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2165-2025%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [CooperVision, Inc. records](https://isitonrecall.com/brand/coopervision-inc/)