Medline Neuro Sponges in Medical Procedure Kits Recalled for Endotoxin
Medline Industries is recalling medical procedure kits containing Medline Neuro Sponges (ANGIO PACK-LF) due to higher-than-expected endotoxin levels that may exceed specifications.
What this means for you
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: This is an FDA Class II recall for a medical device with out-of-specification endotoxin levels. The source text does not report any actual illnesses, injuries, or adverse events, and the hazard is identified through internal testing rather than field incidents, making this a precautionary recall.
Plain-English summary
Medline Industries, LP is recalling Medline medical procedure kits containing Medline Neuro Sponges labeled as ANGIO PACK-LF (Kit Number/SKU DYNJ0774765U, Lot Number 24ILA931). During an internal review, Medline identified higher-than-expected endotoxin levels on a representative neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
The affected kits have been distributed worldwide. Approximately 160 kits are subject to this recall. The product UDI/DI for each kit is 10193489634594, and the case UDI/DI is 40193489634595.
Consumers and healthcare providers in possession of affected kits should discontinue use and contact Medline Industries for instructions on return or replacement.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF, Medline Kit Number/SKU DYNJ0774765U
- Manufacturer
- Medline Industries, LP
- Hazard
- endotoxin
- out-of-specification
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 (3)
- UDI/DI each 10193489634594
- UDI/DI case 40193489634595
- Lot Number: 24ILA931
Distribution
Distribution scope not specified by the agency.
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