Severity
Moderate
FDA Devices recall · Reported October 1, 2025
One lot manufactured with an invalid sterilization cycle.
CooperVision, Inc. recalled MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water … - a moderate-severity action.
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water … was recalled by CooperVision, Inc. in October 1, 2025. Reason: One lot manufactured with an invalid sterilization cycle.. Check the official notice for the remedy. Verify recall #Z-2606-2025 with the FDA Devices before acting.
The recall
CooperVision, Inc. issued this moderate-severity FDA Devices recall-One lot manufactured with an invalid sterilization cycle..
Sourced from official FDA Devices enforcement records. Verify recall #Z-2606-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2606-2025) was formally reported on October 1, 2025, with the manufacturer initiating the action on August 22, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. CooperVision, Inc. is listed as the recalling firm, operating out of West Henrietta, NY. Federal records list the affected scope as 4,140 units.
The documented reason for this recall is: One lot manufactured with an invalid sterilization cycle. Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
4,140 units
Related Recalls
6
3 from same agency
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.
One lot manufactured with an invalid sterilization cycle.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2606-2025 |
| Date reported | October 1, 2025 |
| Date initiated | August 22, 2025 |
| Recalling firm | CooperVision, Inc. |
| Firm location | West Henrietta, NY |
| Affected scope | 4,140 units |
| Distribution | US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 1, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.