# FDA recall Z-0832-2025

> **Cook Biotech, Inc.** · Class II · device recall initiated 2024-11-22.

## Product

Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.

## Reason for recall

Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

## Distribution

US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.

## Key facts

- **Recall number:** Z-0832-2025
- **Recalling firm:** Cook Biotech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-22
- **Report date:** 2025-01-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** W Lafayette, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0832-2025

## Citation

> AI Analytics. FDA recall Z-0832-2025. Retrieved 2026-06-15 from https://api.ai-analytics.org/recall/Z-0832-2025. Source: US FDA. Licensed CC0.

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