# FDA recall Z-2165-2025

> **CooperVision, Inc.** · Class II · device recall initiated 2025-06-16.

## Product

Biofinity XR Toric Contact Lens

## Reason for recall

Lens blisters may have an incomplete or leaking seal which may render them unsterile.

## Distribution

Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.

## Key facts

- **Recall number:** Z-2165-2025
- **Recalling firm:** CooperVision, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-16
- **Report date:** 2025-07-30

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2165-2025

## Citation

> AI Analytics. FDA recall Z-2165-2025. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-2165-2025. Source: US FDA. Licensed CC0.

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