Endoscope Introducer Kit
Recall Summary Medline is recalling three medical procedure kits containing Neuro Sponges used in endoscopic skull base and sinus procedures due to higher-than-expected endotoxin levels that may not meet product specifications. The affected kits are identified by SKU numbers DYNJ58648J, DYNJ66447, and DYNJ908362B. These kits were distributed worldwide to hospitals and medical facilities.
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ58648J; 2. ENT ENDO SINUS WILMINGTON PACK, Medline Kit Number/SKU DYNJ66447; 3. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ908362B.
- 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/5f046b7f-a088-490b-a9eb-1ebf04f91286