Medline Medical Procedure Kits with Neuro Sponges Recalled
Medline Industries is recalling medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels that may be out of specification. The kits were 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 for a sterile medical device with a potential for patient harm (endotoxin contamination can cause adverse reactions). The source text does not report any illnesses or injuries, but the hazard is not purely theoretical as endotoxin presence represents a direct risk-of-harm to patients who would receive these devices in surgical/neurological procedures.
Plain-English summary
Medline Industries, LP is recalling Medline medical procedure kits containing Medline Neuro Sponges. The recalled kits include the NEURO PACK (kit number/SKU DYNJ64479) and CRANIO/NEURO/SPINE (kit number/SKU DYNJ901072D) products. A total of 413 kits have been distributed worldwide.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Healthcare facilities that received these kits should contact Medline for further instructions regarding the recalled products. The recall involves multiple lot numbers across the affected kit models.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO PACK, Medline kit number/SKU DYNJ64479; 2. CRANIO/NEURO/SPINE, Medline kit number/SKU DYNJ901072D.
- Manufacturer
- Medline Industries, LP
- Affected units
- 413
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 (12)
- Medline Kit Number/SKU DYNJ86657A
- UDI/DI each 10198459431678
- UDI/DI case 40198459431679
- Lot Number: 26ABM977
- Lot Number: 25KBM387
- Lot Number: 25IBG995
- Lot Number: 25GBW704
- Medline Kit Number/SKU DYNJT3270
- UDI/DI each 10198459322235
- UDI/DI case 40198459322236
- Lot Number: 26AMF231
- Lot Number: 25GMC304.
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 surgical convenience kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Surgical Convenience Kits with 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 Foot Ankle Convenience Kit Recalled for Shelf-Life Discrepancy
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 Surgical Procedure Kits Recalled Due to Sterility Concerns
FDA (Devices) · 2025-01-08
- HighMedline Neurosponge Kits Recalled for Endotoxin Levels
FDA (Devices) · 2026-09-02
- SevereMedline Neurological Sponges Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Medical Convenience Kits Recalled for Endotoxin Levels
FDA (Devices) · 2026-09-02
- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30