Z-2606-2025 Class II Ongoing
FDA device recall Z-2606-2025 was initiated by CooperVision, Inc. on August 22, 2025 and is designated Class II. Reason for recall: One lot manufactured with an invalid sterilization cycle. The recall status is ongoing. Affected quantity: 4,140 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 1, 2025
- Initiation Date
- August 22, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,140 units
Product Description
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.
Distribution Pattern
US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
Code Information
Carton Lot Number: 20735504301008. Blister Lot Number: 6450505898