The Recall Desk
HighFDA (Devices)·Z-0235-2025·Announced 2024-11-06

Surgical Patties and Strips Recalled for Elevated Endotoxin Levels

Integra LifeSciences is recalling CODMAN Surgical Patties and Strips due to higher-than-expected endotoxin levels in raw material that may result in out-of-specification endotoxin in finished products.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves endotoxin contamination in surgical materials used during sensitive procedures. Per the rubric, this qualifies as High severity: a risk-of-harm medical device product where injury has not yet been reported.

Plain-English summary

Integra LifeSciences Corp. is recalling CODMAN Surgical Patties and Strips (Model 801396), surgical materials used to protect tissue during surgery, including brain and central nervous system tissues. These products are manufactured from COTTONOID material with x-ray detectable markers and suture strings for surgical count verification.

The recall was initiated due to higher-than-expected levels of endotoxin identified in the raw material used to manufacture the patties and strips. This contamination may have resulted in out-of-specification endotoxin levels in finished products.

The recall affects approximately 1,791 units distributed worldwide, including throughout the United States and numerous international markets. Affected products are identified by lot codes UDI# 10381780514923 and 20886704036446. All unexpired products with these codes are subject to this recall.

The recalled product

Product
MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTTONOID¿ Material with x-ray detectable markers. All patties have a suture string attached for ease in performing postsurgical count verification. The surgical
Manufacturer
Integra LifeSciences Corp.
Category
Medical Device — Surgical Supplies
Hazard
  • endotoxin
  • contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot Code: UDI# 10381780514923
  • 2 UDI numbers are listed here for JnJ and for Integra. All unexpired products.

Distribution

Distributed nationwide across the United States.

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