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 material, which may result in out-of-specification endotoxin in finished products.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall involves a high-risk medical device (surgical material for central nervous system use) with a serious contamination hazard. However, the source does not report any illnesses, injuries, or deaths, and no hospitalization events are mentioned. The hazard remains theoretical in terms of actual harm, supporting a High severity rating per the rubric.
Plain-English summary
Integra LifeSciences Corp. is recalling SURG STRP 1X6-200 surgical patties and strips (Catalog Number 801453), which are designed to protect tissue, including the brain and central nervous system tissues, during surgery.
The recall was initiated because testing identified higher-than-expected endotoxin levels in the raw material used to manufacture the products. This contamination may have resulted in finished goods with out-of-specification endotoxin levels.
Approximately 10,719 units were distributed worldwide, including to the United States, Canada, and numerous other countries across Europe, Asia, Africa, and the Americas.
The recalled product
- Product
- SURG STRP 1X6-200 Model/Catalog Number: 801453. 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.
- Affected units
- 10,719
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: 10381780515098
- 2 UDI numbers are listed here for JnJ and for Integra. All unexpired products.
Distribution
Part of a larger recall action
This product is one of 22 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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