The Recall Desk
HighFDA (Devices)·Z-2028-2026·Announced 2026-05-06

Centurion Surgical ENT Prep Kits with Medline Neuro Sponges Recalled

Medline Industries is recalling Centurion Surgical ENT Prep Kits (Medline Neuro Sponges) due to higher-than-expected endotoxin levels that may render the product out-of-specification. Approximately 3,000 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 an FDA Class II recall involving endotoxin contamination, a high-risk pathogen concern. The source states no illnesses or injuries have been reported, but endotoxin presents a theoretical risk of harm on medical devices used in surgical procedures. Per the rubric, high-risk pathogen concerns without reported illness warrant a score of 3.

Plain-English summary

Medline Industries, LP is recalling Centurion Surgical ENT Prep Kits containing Medline Neuro Sponges (Medline Kit Number/SKU MNS11715) due to higher-than-expected endotoxin levels identified during an internal review. The endotoxin contamination indicates that in-market product may be out-of-specification.

Approximately 3,000 kits have been distributed worldwide. The affected product is identified by UDI/DI (each) 10653160323068 and UDI/DI (case) 40653160323069. The recall affects multiple lot numbers, including 23JBY390, 23IBS518, 23FBW067, 23CBO045, 22HBC645, 22GBL079, 22DBP674, 22ABU694, 21IBM298, 21IBM495, 21GBB532, 21EBR576, 21CBL756, 21ABI942, 26ABG606, 25LBS129, 25IBK286, 25GBB222, 25DBH934, 25BBD132, 24LBO080, 24JBW176, 24HBT740, 24EBU727, and 24ABW463.

Healthcare facilities and individuals who have received these kits should discontinue use and contact Medline Industries, LP for further instructions regarding the recall.

The recalled product

Product
Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline Kit Number/SKU MNS11715
Manufacturer
Medline Industries, LP
Category
Medical Device — Surgical / ENT 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)

  • UDI/DI EACH 10653160323068
  • UDI/DI case 40653160323069. Lot Numbers: 23JBY390
  • 23IBS518
  • 23FBW067
  • 23CBO045
  • 22HBC645
  • 22GBL079
  • 22DBP674
  • 22ABU694
  • 21IBM298
  • 21IBM495
  • 21GBB532
  • 21EBR576
  • 21CBL756
  • 21ABI942
  • 26ABG606
  • 25LBS129
  • 25IBK286
  • 25GBB222
  • 25DBH934

Distribution

Distribution scope not specified by the agency.

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