Data Foundry

Medical device recalls 2025

MyDay Toric — Class II medical device recall Z-2606-2025

Ongoing recall by CooperVision, Inc., reported 2025-10-01, distributed nationwide. One lot manufactured with an invalid sterilization cycle.

Recall numberZ-2606-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCooperVision, Inc., West Henrietta, NY, United States
Recall initiated2025-08-22
Classified2025-09-19
Reported by FDA2025-10-01
DistributedNationwide (US)
Quantity4,140 units
Lot numbers20735504301008, 6450505898

Product

MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.

Reason for recall

One lot manufactured with an invalid sterilization cycle.

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-2606-2025. 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.