The Recall Desk
ModerateFDA (Devices)·Z-2008-2026·Announced 2026-05-06

Medline Neuro Sponges recalled for out-of-specification endotoxin levels

Medline Industries is recalling Medline Neuro Sponges in multiple sizes worldwide after internal review found higher-than-expected endotoxin levels in representative product samples.

What this means for you

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: FDA classified this as a Class II recall. The source text states only that endotoxin levels are out-of-specification with no reported illnesses or injuries, making this a precautionary recall based on a detected deviation rather than confirmed harm.

Plain-English summary

Medline Industries, LP is recalling Medline Neuro Sponges in eight size variations (ranging from 0.25" X 0.25" to 1" X 3"), distributed worldwide. The recall affects approximately 4,225,160 units across all lot numbers for each SKU.

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Neuro Sponge product sample. This indicates that in-market product may be out-of-specification for endotoxin content.

Healthcare facilities and practitioners who have received these products should contact Medline Industries for further guidance. Specific UDI/DI codes and lot information for each of the eight affected SKUs are available through the FDA or Medline.

The recalled product

Product
Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" X 0.25", XR, 10/PK, Medline SKU NEUROSPNG02; 2. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 0.5", XR, 10/PK, Medline SKU NEUROSPNG05; 3. Neu
Manufacturer
Medline Industries, LP
Category
Medical Device — Surgical / Wound Care
Hazard
  • endotoxin

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 (18)

  • 1. NEUROSPNG02: UDI/DI each 10197344111572
  • UDI/DI case 20197344111579
  • ALL LOTS
  • 2. NEUROSPNG05: UDI/DI each 20080196286659
  • UDI/DI case 30080196286656
  • 3. NEUROSPNG06: UDI/DI each 20080196286505
  • UDI/DI case 30080196286502
  • 4. NEUROSPNG07: UDI/DI each 10080196286485
  • UDI/DI case 40080196286486
  • 5. NEUROSPNG09: UDI/DI each 20080196286536
  • UDI/DI case 30080196286533
  • 6. NEUROSPNG11: UDI/DI each 20080196286550
  • UDI/DI case 30080196286557
  • 7. NEUROSPNG13: UDI/DI each 10080196286577
  • UDI/DI case 40080196286578
  • 8. NEUROSPNG14: UDI/DI each 10080196286584
  • UDI/DI case 40080196286585
  • ALL LOTS.

Distribution

Distribution scope not specified by the agency.

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