Medline Neuro Sponges Cervical Pack Kits Recalled for Endotoxin
Medline Industries is recalling medical procedure kits containing Medline Neuro Sponges (Cervical Pack) due to higher-than-expected endotoxin levels that may be out-of-specification.
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 with no reported illnesses or injuries. The source text identifies a specification deviation (higher-than-expected endotoxin) but does not report any adverse health events or clinical consequences, placing this in the moderate category per the rubric criterion for low-risk or precautionary recalls.
Plain-English summary
Medline Industries, LP is recalling Medline medical procedure kits containing Medline Neuro Sponges labeled as Cervical Pack (Kit Number/SKU DYNJ37902F). The recall involves approximately 340 kits that were distributed worldwide.
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. Affected lot numbers are 21GBA316, 21FBA411, 21DBI004, and 21BBS142. The UDI/DI for each unit is 10889942930883 and for case is 40889942930884.
Customers who have received these kits should contact Medline Industries, LP for instructions on how to proceed. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACK, Medline Kit Number/SKU DYNJ37902F
- Manufacturer
- Medline Industries, LP
- Affected units
- 340
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 (6)
- UDI/DI each 10889942930883
- UDI/DI case 40889942930884
- Lot Numbers: 21GBA316
- 21FBA411
- 21DBI004
- 21BBS142.
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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