FDAClass IIMay 6, 2026

Medline medical procedure kits recall: Endotoxin

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I

Why was Medline medical procedure kits recalled?

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 should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI each 10195327487546, UDI/DI case 40195327487547, Lot Numbers: 24KME456, 24HMJ900.

Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I
Recalling firm
Medline Industries, LP
Quantity
380 kits
Distribution
Worldwide distribution.
Recall date
May 6, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls