# FDA recall Z-0262-2025

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2024-09-26.

## Product

Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US  Lot CT007694

## Reason for recall

Out of specification endotoxin levels.

## Distribution

China

## Key facts

- **Recall number:** Z-0262-2025
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-26
- **Report date:** 2024-11-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0262-2025

## Citation

> AI Analytics. FDA recall Z-0262-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0262-2025. Source: US FDA. Licensed CC0.

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