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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Hazard
- Affected units
- 3,000
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.
Part of a larger recall action
This product is one of 31 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 31 products in this recall →Related recalls
Same manufacturer · Medline Industries, LP
See all →- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Homecare Beds Recalled for Fire Hazard in Hand Control Pendant
FDA (Devices) · 2026-10-07
- SevereMedline Homecare Bed Hand Pendants Recalled for Fire Hazard
FDA (Devices) · 2026-10-07
- HighMedline Instrument Channel Brush Kits Recalled for Sharp Edges
FDA (Devices) · 2026-09-30
Same hazard · endotoxin
See all →- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Craniotomy Kits Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- SevereMedline Neurological Sponges Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Neurological Sponges Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
Similar recalls
- HighMedline Medical Convenience Kits Recalled for Endotoxin Levels
FDA (Devices) · 2026-09-02
- HighMedline Neurosurgical Kits Recalled for Endotoxin Contamination
FDA (Devices) · 2026-09-02
- SevereMedline Neurological Sponges Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Neurosponge Kits Recalled for Endotoxin Levels
FDA (Devices) · 2026-09-02
- HighMedline Surgical Patties and Strips Recalled for Out-of-Spec Endotoxin Contamination
FDA (Devices) · 2025-01-01
- HighMedline Surgical Procedure Kits Recalled Due to Sterility Concerns
FDA (Devices) · 2025-01-08