The Recall Desk
HighFDA (Devices)·Z-2011-2026·Announced 2026-05-06

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.

What this means for you

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
Category
Medical Device — Surgical / Spinal Fusion Kit
Hazard
  • endotoxin
  • sterility-violation

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.

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