Z-2031-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2026
- Initiation Date
- March 19, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 380 kits
Product Description
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I
Reason for Recall
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.
Distribution Pattern
Worldwide distribution.
Code Information
UDI/DI each 10195327487546, UDI/DI case 40195327487547, Lot Numbers: 24KME456, 24HMJ900.