Surgical Patties and Strips Recalled for Elevated Endotoxin Levels
Integra LifeSciences Corp. is recalling surgical patties and strips (Model 801402) used in surgery due to higher-than-expected endotoxin levels in raw materials that may affect the finished product.
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 is an FDA Class II recall of a medical device used in critical neurosurgery with identified endotoxin contamination. While no illnesses or injuries have been reported, the contamination of a device intended for brain and central nervous system surgery represents a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Integra LifeSciences Corp. is recalling SURG PAT XRAY 1/2X1 surgical patties and strips (Model/Catalog Number 801402). These devices are medical-grade materials indicated for protecting tissue, including brain and central nervous system tissues, during surgical procedures.
The recall was initiated after higher-than-expected levels of endotoxin were identified in the raw materials used to manufacture these products. Endotoxin is a bacterial substance that may result in out-of-specification levels in the finished medical devices, potentially posing risks during surgical use.
Approximately 80,515 units have been distributed worldwide, including to facilities in the United States, Canada, and numerous countries across Europe, Asia, Africa, and the Americas. The affected products are identified by UDI numbers 10381780514985 and 20886704036507, with all unexpired units potentially affected.
Healthcare facilities that have received these products should stop using them immediately and contact Integra LifeSciences Corp. for instructions on returns or replacement. This is an FDA Class II recall.
The recalled product
- Product
- SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. 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.
- Hazard
- Affected units
- 80,515
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#: 10381780514985
- 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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