Surgical patties and strips recalled for elevated endotoxin levels
Integra LifeSciences is recalling surgical patties and strips (Model 801409) used in surgery due to higher-than-expected endotoxin levels detected in raw materials. No illnesses have been reported.
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: FDA Class II medical device with confirmed endotoxin contamination in finished goods, but no reported illnesses or injuries. Product is used in high-risk surgical contexts, particularly near central nervous system tissue, fitting the rubric's classification of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Surgical patties and strips Model 801409, manufactured by Integra LifeSciences Corp., are being recalled. These medical devices are used during surgical procedures to protect tissues, including brain and other central nervous system tissue.
The recall addresses higher-than-expected endotoxin levels detected in raw materials used to manufacture the product, which resulted in finished goods with out-of-specification endotoxin levels.
Approximately 9,563 units of the recalled product have been distributed worldwide, including throughout the United States and to multiple countries including Canada, Germany, United Kingdom, Australia, Japan, and numerous others. All unexpired products are included in this recall.
Healthcare providers and surgical facilities with the affected product should stop using it immediately and contact Integra LifeSciences Corp. for guidance on returns, replacement, or disposal. Patients who underwent procedures using these devices should discuss any concerns with their healthcare provider.
The recalled product
- Product
- SURG PAT XRAY 3X3 Model/Catalog Number: 801409. 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
- 9,563
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: 10381780515043
- 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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