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.
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: 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
- Affected units
- 160
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.
Part of a larger recall action
This product is one of 31 recalled by Medline Industries, LP 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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