The Recall Desk
HighFDA (Devices)·Z-2013-2026·Announced 2026-05-06

Medline Medical Procedure Kits with Neuro Sponges Recalled

Medline Industries is recalling medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels that may be out of specification. The kits were distributed worldwide.

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 recall for a sterile medical device with a potential for patient harm (endotoxin contamination can cause adverse reactions). The source text does not report any illnesses or injuries, but the hazard is not purely theoretical as endotoxin presence represents a direct risk-of-harm to patients who would receive these devices in surgical/neurological procedures.

Plain-English summary

Medline Industries, LP is recalling Medline medical procedure kits containing Medline Neuro Sponges. The recalled kits include the NEURO PACK (kit number/SKU DYNJ64479) and CRANIO/NEURO/SPINE (kit number/SKU DYNJ901072D) products. A total of 413 kits have been distributed worldwide.

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

Healthcare facilities that received these kits should contact Medline for further instructions regarding the recalled products. The recall involves multiple lot numbers across the affected kit models.

The recalled product

Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO PACK, Medline kit number/SKU DYNJ64479; 2. CRANIO/NEURO/SPINE, Medline kit number/SKU DYNJ901072D.
Manufacturer
Medline Industries, LP
Category
Medical Device — Surgical Sponges / Neuro
Hazard
  • endotoxin
  • sterile-device-contamination

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 (12)

  • Medline Kit Number/SKU DYNJ86657A
  • UDI/DI each 10198459431678
  • UDI/DI case 40198459431679
  • Lot Number: 26ABM977
  • Lot Number: 25KBM387
  • Lot Number: 25IBG995
  • Lot Number: 25GBW704
  • Medline Kit Number/SKU DYNJT3270
  • UDI/DI each 10198459322235
  • UDI/DI case 40198459322236
  • Lot Number: 26AMF231
  • Lot Number: 25GMC304.

Distribution

Distribution scope not specified by the agency.

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