Ear, Nose, And Throat Surgical Tray
Medline and Centurion medical procedure kits containing Medline Neuro Sponges are being recalled because testing found higher-than-expected endotoxin levels, meaning the products may not meet safety specifications. The recall affects 1,229 kits used in ear, nose, and throat surgical procedures and has been distributed worldwide. This is a Class I recall, which indicates a serious safety concern.
- Product
- Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, 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 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/96f06e9f-dd3f-4bbd-b3cb-eee4630664a4