Medline medical procedure kits recalled for out-of-specification endotoxin levels
Medline Industries is recalling medical procedure kits containing Neuro Sponges for spinal fusion 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 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 an FDA Class II medical device recall involving an out-of-specification condition (elevated endotoxin) that could pose a risk of harm. Although no illnesses or injuries are reported in the source text, endotoxin is a known hazard that could cause adverse reactions in surgical applications, and the source does not explicitly state that the risk is theoretical only.
Plain-English summary
Medline Industries, LP is recalling Medline medical procedure kits containing Medline Neuro Sponges labeled for spinal fusion (Kit Number/SKU CDS860017AG). 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. Affected lot numbers are: 25LBI308, 25JBH227, 25HBQ371, 25HBP069, 25GBQ494, 25FBM672, 25CBF603, 25BBG224, 25ABN190, and 25ABN214. The device identifiers (UDI/DI) are 10198459237317 (each) and 40198459237318 (case).
Healthcare facilities and individuals who have these kits should stop using them and contact Medline Industries or the FDA for instructions on how to proceed. The source text does not specify what action Medline or healthcare providers recommend for kits already in use or distributed to patients.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline Kit Number/SKU CDS860017AG
- Manufacturer
- Medline Industries, LP
- Affected units
- 120
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 (11)
- UDI/DI each 10198459237317
- UDI/DI case 40198459237318: Lot Numbers: 25LBI308
- 25JBH227
- 25HBQ371
- 25HBP069
- 25GBQ494
- 25FBM672
- 25CBF603
- 25BBG224
- 25ABN190
- 25ABN214.
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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