The Recall Desk
HighFDA (Devices)·Z-0253-2025·Announced 2024-11-06

Surgical Patties and Strips Recalled for Higher-Than-Expected Endotoxin Levels

Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw material that may result in out-of-specification finished products. The recall affects 2,056 units distributed worldwide.

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 FDA medical device recall involving endotoxin contamination in surgical protective devices used in neurosurgery. No illnesses or deaths are mentioned in the source text, making this a potential-risk scenario. This matches the rubric criterion 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Integra LifeSciences Corp. is recalling Surgical Patties and Strips (Model/Catalog Number 801454), devices used during surgery to protect tissue, including brain and central nervous system tissues. Approximately 2,056 units have been identified for recall.

The company identified higher-than-expected levels of endotoxin in the raw material used to manufacture these products. Endotoxin is a bacterial component found in contaminated materials. The elevated levels in raw material may have resulted in finished goods with out-of-specification endotoxin content.

The affected products were distributed worldwide, including throughout the United States, Canada, and numerous other countries. This is a Class II recall. Healthcare facilities and surgical centers that may have received these products should review their inventory.

For questions about affected products or to report adverse events, healthcare providers and patients should contact Integra LifeSciences Corp. or the FDA.

The recalled product

Product
SURG STRP 1-1/2X6 Model/Catalog Number: 801454. 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 Device
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: 10381780515104
  • 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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