The Recall Desk
HighFDA (Devices)·Z-0255-2025·Announced 2024-11-06

Surgical Patties and Strips Recalled for Higher Endotoxin Levels

Integra LifeSciences is recalling Surgical Patties and Strips (Model 801456) due to higher-than-expected endotoxin levels in raw materials. These surgical devices are used for tissue protection during surgery, including CNS procedures.

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 CNS tissue protection represents a risk-of-harm scenario with no reported illnesses or injuries. FDA Class II classification with theoretical hazard places this at Score 3, the maximum for recalls without documented adverse events.

Plain-English summary

Integra LifeSciences Corp. is recalling Surgical Patties and Strips (Model/Catalog Number 801456) worldwide. The recall was initiated due to higher-than-expected levels of endotoxin identified in the raw material used to manufacture these devices. Testing revealed that some finished units may have endotoxin levels that exceed specifications.

Approximately 1,454 units of the affected product have been distributed worldwide to healthcare facilities. These surgical patties and strips are indicated for use in protecting tissue, including brain and other tissues of the central nervous system, during surgical procedures.

Healthcare facilities that have received these products should discontinue use and quarantine any remaining units with UDI-DI numbers 10381780515128 or 20886704036644. Affected units should be returned to Integra LifeSciences Corp. Healthcare providers should report any adverse events or concerns to the manufacturer or the FDA.

No illnesses or injuries have been reported associated with this recall to date. However, elevated endotoxin levels in surgical devices used during procedures involving sensitive tissues pose a potential risk of inflammatory complications.

The recalled product

Product
SURG STRP 3X6 Model/Catalog Number: 801456. 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
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: 10381780515128
  • 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