Neurosurgical Paddie

Recall Summary Medline is recalling Neuro Sponges (1x1 inch, 10-pack, Kit Number DNSC38133) that were distributed worldwide as part of medical procedure kits. The sponges were found to have higher-than-expected endotoxin levels, meaning they may not meet safety specifications. This is a Class II recall, indicating a potential health hazard.

Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline Kit Number/SKU DNSC38133
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
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-03-19
Status
Open, Classified
Distribution
Worldwide distribution.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/7f718bbe-9173-45de-a5ec-ea7791b7b768