# FDA recall Z-0909-2023

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2022-12-02.

## Product

Codman Surgical Patties, Part number 801400; SURG PATXRAY  1/2X1/2-200; Lot 6396457

## Reason for recall

Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of CA, CO, CT, FL, IN,  KY, MA, MI, MO, NC, NJ, NY, OH, PA, TX, VA, WV and the countries of Chile, Australia, New Zealand, France, Romania, United Kingdom, and Ireland.

## Key facts

- **Recall number:** Z-0909-2023
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-02
- **Report date:** 2023-01-18

- **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-0909-2023

## Citation

> AI Analytics. FDA recall Z-0909-2023. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-0909-2023. Source: US FDA. Licensed CC0.

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