# FDA recall Z-3261-2024

> **Cook Biotech, Inc.** · Class II · device recall initiated 2024-08-07.

## Product

Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias.   Order Number (GPN): G46603

## Reason for recall

Products expire prior to the expiration date printed on the product labeling

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada,  China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand,  Norway, South Africa, United Kingdom.

## Key facts

- **Recall number:** Z-3261-2024
- **Recalling firm:** Cook Biotech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-07
- **Report date:** 2024-10-02

- **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-3261-2024

## Citation

> AI Analytics. FDA recall Z-3261-2024. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-3261-2024. Source: US FDA. Licensed CC0.

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