The Recall Desk
HighFDA (Devices)·Z-0236-2025·Announced 2024-11-06

Codman Surgical Patties Recalled for Endotoxin Contamination

Integra LifeSciences Corp. is recalling Codman Surgical Patties and Strips due to endotoxin contamination in raw material that may result in out-of-spec finished products. The devices protect tissue during surgery, including the brain.

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: Endotoxin contamination in surgical devices used for brain and central nervous system protection represents a risk-of-harm product scenario without reported injury. FDA Class II classification with no reported illnesses or injuries places this at the high end per the rubric criterion for risk-of-harm products without documented harm.

Plain-English summary

Integra LifeSciences Corp. is recalling Codman Surgical Patties and Strips (Model 801397). These medical devices are used during surgery to protect tissue, including the brain and other tissues of the central nervous system.

The recall was initiated due to higher-than-expected levels of endotoxin detected in the raw material used to manufacture the devices. This contamination may have resulted in finished products with endotoxin levels that exceed product specifications.

Approximately 2,615 units were distributed worldwide, including throughout the United States, Canada, and numerous other countries. All unexpired products bearing the affected UDI numbers (10381780514930 and 20886704036453) are included in this recall.

The recalled product

Product
SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Manufacturer
Integra LifeSciences Corp.
Category
Medical Device — Surgical Supplies
Hazard
Affected units
2,615

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# 10381780514930
  • 2 UDI numbers are listed here for JnJ and for Integra. All unexpired products.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 22 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 22 products in this recall →

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