The Recall Desk
HighFDA (Devices)·Z-0250-2025·Announced 2024-11-06

Surgical Patties and Strips Recalled for Elevated Endotoxin Levels

Integra LifeSciences is recalling surgical patties and strips (Model 801451) worldwide due to higher-than-expected endotoxin levels in raw materials that may result in out-of-specification contamination.

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 is an FDA Class II medical device recall for endotoxin contamination in surgical products used in high-risk procedures. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported receive a score of 3 (High).

Plain-English summary

Integra LifeSciences Corp. is recalling SURG STRP 1/2X6 surgical patties and strips (Model/Catalog Number 801451) because higher-than-expected endotoxin levels were identified in the raw materials used to manufacture these products. These elevated endotoxin levels may have resulted in out-of-specification endotoxin in the finished goods.

These surgical patties and strips are medical devices used during surgery to protect tissue, including brain and other tissues of the central nervous system. Endotoxin contamination in surgical devices poses a potential concern for patient safety during surgical procedures.

The recalled products have been distributed worldwide, including the United States, Canada, and numerous international locations. All unexpired products bearing the UDI codes 10381780515074 and 20886704036590 are included in this recall.

Healthcare providers and facilities in possession of these products should contact Integra LifeSciences Corp. for guidance on product replacement and proper disposition.

The recalled product

Product
SURG STRP 1/2X6 Model/Catalog Number: 801451. 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 / Tissue Protection
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)

  • UDI-DI: 10381780515074
  • 2 UDI numbers are listed here for JnJ and for Integra. All unexpired products.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category