Z-2009-2026 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
- 306 kits
Product Description
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: PEDS AIRWAY PACK, Medline Kit Number SKU DYNJ86657A
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
Medline Kit Number SKU DYNJ86657A: UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Numbers: 26ABM977, 25KBM387, 25IBG995, 25GBW704.