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. The contamination may have resulted in out-of-specification 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: The recall involves FDA Class II medical devices with confirmed endotoxin contamination exceeding product specifications. While endotoxin in surgical devices poses a potential risk, no adverse events have been reported, limiting the severity to High per the rubric.
Plain-English summary
Integra LifeSciences Corp. is recalling surgical patties and strips (Model/Catalog Number 801450). These devices are indicated for use during surgery to protect tissue, including brain and other tissues of the central nervous system.
The manufacturer identified higher-than-expected endotoxin levels in the raw material used to manufacture these devices. This contamination may have resulted in out-of-specification endotoxin levels in the finished products. Endotoxin is a pyrogenic substance that must be controlled in medical devices.
The affected products were distributed worldwide to numerous countries. Approximately 6,706 units have been distributed, and all unexpired products are subject to this recall.
Facilities and healthcare providers using these devices should contact Integra LifeSciences Corp. or the FDA with any questions about the recall or to report any adverse events.
The recalled product
- Product
- SURG STRP 1/4X6 Model/Catalog Number: 801450. 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
- 6,706
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: 10381780515067
- 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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