Tray, Surgical
Recall Summary Medline is recalling Centurion medical procedure kits (SKU MNS11715) containing Medline Neuro Sponges used in surgical procedures because testing found higher-than-expected endotoxin levels on the sponges. This product has been distributed worldwide and is classified as a Class I recall, the most serious category.
- Product
- Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline Kit Number/SKU MNS11715
- 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 I
- 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/6b321229-1c29-4d15-902a-eaff0fb99d52