The Recall Desk
HighFDA (Devices)·Z-2022-2026·Announced 2026-05-06

Medline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin

Medline is recalling medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may exceed specifications. Approximately 21,288 kits have been 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 a Class II medical device recall involving sterile surgical products where the hazard (endotoxin contamination) is a high-risk pathogenic concern. Although no illnesses have been reported, the out-of-specification endotoxin levels on a representative product indicate risk of harm to patients undergoing surgical procedures.

Plain-English summary

Medline Industries, LP is recalling 61 different medical procedure kits that contain Medline Neuro Sponges. The kits are used for various surgical procedures including free flap, neurosurgical, otolaryngology, and endoscopy procedures. The affected kits have been distributed worldwide.

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. Endotoxins are substances that can trigger inflammatory responses in the body and may pose a health risk if present above acceptable limits.

Healthcare facilities and surgical centers using these kits should discontinue use of all affected lots and consult the recalled product list for the specific kit numbers (SKUs) and lot numbers involved. Customers with questions about the recall should contact Medline directly.

The recalled product

Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS FREE FLAP, Medline Kit Number/SKU CDS983493N; 2. TLIF PACK, Medline Kit Number/SKU DYNJ02476O; 3. DONOR FREE FLAP PACK-LF, Medline Kit Number/SKU DYNJ0426069N; 4. DONOR FREE
Manufacturer
Medline Industries, LP
Category
Medical Device — Surgical Procedure Kits
Hazard
  • endotoxin
  • 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 (20)

  • Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218
  • UDI/DI case 40198459000219
  • Lot Number: 25EDA675
  • Lot Number: 25CDA718
  • Lot Number: 25BDA328
  • Lot Number: 24KDB408
  • Lot Number: 24KDA607
  • Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478
  • UDI/DI case 40195327119479
  • Lot Number: 23HMH658
  • Lot Number: 23GMD341
  • Lot Number: 23EMB793
  • Lot Number: 23CMG372
  • Lot Number: 23BMI499
  • Lot Number: 22JMF967
  • Lot Number: 22EMC648
  • Lot Number: 22CMD889
  • Lot Number: 24EMH897
  • Lot Number: 24DMF264
  • Lot Number: 24BMJ904

Distribution

Distribution scope not specified by the agency.

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