Medline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin
Medline is recalling 22,116 medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may be out-of-specification. The products are distributed worldwide.
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: This is a Class II medical device recall for a sterile product with a potential contamination hazard (out-of-specification endotoxin). Endotoxin is a pyrogenic substance that could cause harm in sterile procedures, and no reported illnesses have been documented, placing this at the upper end of High severity per the rubric.
Plain-English summary
Medline Industries, LP is recalling 22,116 medical procedure kits containing Medline Neuro Sponges due to endotoxin concerns. 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 recalled kits have been distributed worldwide. Multiple kit models and lot numbers are affected, including SKUs CDS980375L, CDS980375M, CDS982939U, CDS983100D, CDS983173I, CDS983493L, CDS983493M, CDS983493O, and various DYN models.
Customers who have received affected kits should stop use and contact Medline Industries, LP for instructions on replacement or return. Healthcare facilities should review their inventory using the provided kit numbers, SKUs, UDI codes, and lot numbers to identify affected products.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges (102 in total)
- Manufacturer
- Medline Industries, LP
- Affected units
- 22,116
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 (20)
- Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882
- UDI/DI case 40193489922883
- Lot Number: 23KBN711
- Lot Number: 23GBD593
- Lot Number: 23GBD781
- Lot Number: 23DBF906
- Lot Number: 22LBI985
- Lot Number: 22KBC504
- Lot Number: 22IBF741
- Lot Number: 22FBX069
- Lot Number: 22DBS948
- Lot Number: 22CBX667
- Lot Number: 21IBT137
- Lot Number: 21HBG608
- Lot Number: 25GBV215
- Lot Number: 25GBA852
- Lot Number: 24KBJ988
- Lot Number: 24JBC528
- Lot Number: 24IBV131
- Lot Number: 24IBP386
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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