The Recall Desk
HighFDA (Devices)·Z-0237-2025·Announced 2024-11-06

Surgical Patties and Strips Recalled for Endotoxin Contamination

Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw materials used during manufacturing. The affected devices were distributed worldwide to healthcare facilities.

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 a Class II medical device recall with no reported illnesses or injuries. The product is used in high-risk surgical contexts, particularly in central nervous system procedures. However, the endotoxin contamination is theoretical (may have resulted), not confirmed in clinical outcomes. Per the rubric, risk-of-harm products without reported injury score at 3 (High).

Plain-English summary

Integra LifeSciences Corp. is recalling Surgical Patties and Strips, catalog number 801398, due to the identification of higher-than-expected endotoxin levels in the raw material used to manufacture these products. The contamination may have resulted in the finished surgical devices containing out-of-specification endotoxin levels.

The affected products are sterile surgical patties and strips indicated for use in protecting tissue, including brain and central nervous system tissues, during surgical procedures. Approximately 2,894 units of the affected product were distributed worldwide to healthcare facilities in the United States, Canada, Germany, United Kingdom, and numerous other countries.

Healthcare providers and surgical facilities should verify whether they have received the affected product. The product is identified by the affected lot codes as referenced in the recall notice.

The recalled product

Product
SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. 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 Patties and Strips
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)

  • Lot Code: UDI# 10381780514947
  • 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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