Biofinity XR Toric Contact Lens — Class II medical device recall Z-2165-2025
Ongoing recall by CooperVision, Inc., reported 2025-07-30, distributed nationwide. Lens blisters may have an incomplete or leaking seal which may render them unsterile.
| Recall number | Z-2165-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperVision, Inc., Scottsville, NY, United States |
| Recall initiated | 2025-06-16 |
| Classified | 2025-07-23 |
| Reported by FDA | 2025-07-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, HN, MX |
| Quantity | 397 units |
| Reason classes | packaging |
| 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 and 38 more |
Product
Biofinity XR Toric Contact Lens
Reason for recall
Lens blisters may have an incomplete or leaking seal which may render them unsterile.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2165-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.