Official recall notice
FDA DeviceClass IINotable
FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLE
- Recall date
- 2026-05-06
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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.
Recommended action
What to do
208 kits
Product description
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.