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.
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 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…
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 1,824
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.
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 →- ModerateMedline Foot Ankle Convenience Kit Recalled for Shelf-Life Discrepancy
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- ModerateMedline surgical convenience kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21
- SevereMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alerts
FDA (Devices) · 2026-10-21
Same hazard · endotoxin
See all →- 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
- SevereMedline Neurological Sponges Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Craniotomy Kits Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
Similar recalls
- HighMedline Neurosurgical Kits Recalled for Endotoxin Contamination
FDA (Devices) · 2026-09-02
- HighMedline Custom Surgical Procedure Kits Recalled for Potential Endotoxin Contamination
FDA (Devices) · 2025-01-08
- HighMedline Medical Convenience Kits Recalled for Endotoxin Levels
FDA (Devices) · 2026-09-02
- HighMedline Neurosponge Kits Recalled for Endotoxin Levels
FDA (Devices) · 2026-09-02
- HighMedline Surgical Procedure Kits Recalled Due to Sterility Concerns
FDA (Devices) · 2025-01-08
- HighMedline surgical procedure kits recalled for potential endotoxin contamination
FDA (Devices) · 2025-01-08