HIGH

Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, ACDF, ENT, etc.

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.

Quick Facts at a Glance

Recall Date
March 19, 2026
Hazard Level
HIGH
Brand
Medline Industries, LP

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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Full Description

Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, ACDF, ENT, etc.. Reason: 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.. Classification: Class II. Quantity: 263739 kits. Distribution: Worldwide distribution.

Safety Guide

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Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
Medline Kit Number/SKU BIOB110: UDI/DI each 10889942758043
UDI/DI case 40889942758044
Lot Number: 24HBM826
Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562
UDI/DI case 40195327045563
+5 more
Report Date
May 6, 2026
Recall Status
ACTIVE

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