# FDA recall Z-2607-2025

> **CooperVision, Inc.** · Class II · device recall initiated 2025-08-22.

## Product

Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables.    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

US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.

## Key facts

- **Recall number:** Z-2607-2025
- **Recalling firm:** CooperVision, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-22
- **Report date:** 2025-10-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Henrietta, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2607-2025

## Citation

> AI Analytics. FDA recall Z-2607-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2607-2025. Source: US FDA. Licensed CC0.

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