The Recall Desk
HighFDA (Devices)·Z-2023-2026·Announced 2026-05-06

Medline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin

Medline Industries is recalling three medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels identified during internal review. The affected kits may be out-of-specification for endotoxin.

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 of a medical device (neurosurgical/ENT sponges) with a high-risk contamination hazard (endotoxin). Although no illnesses or injuries are reported in the source text, endotoxin contamination in surgical sponges used in skull-base and sinus procedures poses a significant risk of harm to patients, meeting the High severity threshold.

Plain-English summary

Medline Industries, LP is recalling medical procedure kits containing Medline Neuro Sponges. The recall affects three kit types: ENDOSCOPIC SKULL BASE (Medline Kit Number DYNJ58648J and DYNJ908362B) and ENT ENDO SINUS WILMINGTON PACK (Medline Kit Number DYNJ66447). A total of 1,824 kits have been distributed worldwide.

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

Healthcare providers and facilities using these kits should identify affected product by the kit numbers and lot numbers listed and stop use. Patients or healthcare providers with questions or concerns should contact Medline Industries, LP.

The recalled product

Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ58648J; 2. ENT ENDO SINUS WILMINGTON PACK, Medline Kit Number/SKU DYNJ66447; 3. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ90836
Manufacturer
Medline Industries, LP
Category
Medical Device — Surgical Sponges / Endoscopic Tools
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 DYNJ58648J: UDI/DI each 10195327212124
  • UDI/DI case 40195327212125
  • Lot Number: 23JMD938
  • Lot Number: 23HMG766
  • Lot Number: 23DMD129
  • Lot Number: 22KMD675
  • Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793
  • UDI/DI case 40193489356794
  • Lot Number: 23JBM687
  • Lot Number: 23EBD581
  • Lot Number: 23DBH247
  • Lot Number: 23CBS705
  • Lot Number: 23BBF189
  • Lot Number: 22JBF016
  • Lot Number: 22HBR972
  • Lot Number: 22DBO928
  • Lot Number: 22DBO407
  • Lot Number: 24ABP390
  • Lot Number: 23LBN206
  • Medline Kit Number/SKU DYNJ908362B: UDI/DI each 10195327404468

Distribution

Distribution scope not specified by the agency.

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