The Recall Desk
HighFDA (Devices)·Z-0251-2025·Announced 2024-11-06

Surgical Patties and Strips Recalled for Elevated Endotoxin Levels

Integra LifeSciences is recalling surgical patties and strips (Model 801452) due to higher-than-expected endotoxin levels in raw materials that may result in out-of-specification contamination. Approximately 4,818 units are affected.

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 product involves a high-risk bacterial contamination hazard (endotoxin) in a device intended for critical CNS surgical use. No illnesses or injuries have been reported, and the source states the contamination is theoretical (may have resulted), which per FDA rubric limits the score to High despite the serious application and Class II classification.

Plain-English summary

Integra LifeSciences Corp. is recalling Surgical Strips and Patties (Model 801452) that are indicated for use in protecting tissue during surgical procedures, including brain and central nervous system tissue. Approximately 4,818 units have been recalled.

The recall was initiated due to identification of higher-than-expected levels of endotoxin in the raw materials used to manufacture these devices. Endotoxin, a bacterial contaminant, may have resulted in out-of-specification endotoxin levels in the finished surgical strips and patties.

The affected products were distributed worldwide to numerous countries and territories including the United States, Canada, Germany, the United Kingdom, and many others. All unexpired products bearing the affected UDI-DI codes (10381780515081 and 20886704036606) are subject to this recall.

The recalled product

Product
SURG STRP 3/4X6 Model/Catalog Number: 801452. 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 / CNS Protection
Hazard
  • endotoxin

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)

  • UDI-DI: 10381780515081
  • 2 UDI numbers are listed here for JnJ and for Integra. All unexpired products.

Distribution

Distributed nationwide across the United States.

Related recalls

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