Codman Surgical Patties Recalled for Out-of-Specification Endotoxin Levels
Integra LifeSciences is recalling one lot of Codman Surgical Patties due to out-of-specification endotoxin levels. The potential risk is a minor, transient fever.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II medical device recall with no reported illnesses or injuries. The worst-case risk is a potentially minor, transient fever from out-of-specification endotoxin levels, representing low-risk contamination.
Plain-English summary
Integra LifeSciences Corp. is recalling one lot (Lot 6396457) of Codman Surgical Patties (Part number 801400). The recall was initiated after the manufacturer identified that this lot was released with out-of-specification endotoxin results.
The worst-case risk for patients is a potentially minor, transient fever. No illnesses or injuries have been reported in connection with this recall.
The affected lot was distributed to 168 units in the United States across the following states: California, Colorado, Connecticut, Florida, Indiana, Kentucky, Massachusetts, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia, and West Virginia. Three additional units were distributed outside the United States to Chile, Australia, New Zealand, France, Romania, United Kingdom, and Ireland.
The recalled product
- Product
- Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
- Manufacturer
- Integra LifeSciences Corp.
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 (1)
- UDI-DI 10381780514961 Lot Number: 6396457 Expiration date 06/30/2027
Distribution
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