Class IIDeviceOngoing

Medline Industries, LP

Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A

Reason for recall

The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

Details

Recall number: Z-3266-2026
Event ID: 99739
Recall initiated: Aug 10, 2026
Classified: Sep 24, 2026
Reported: Sep 30, 2026
Quantity: 128 kits
Distribution: US Nationwide.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Northfield, IL, United States
Lot / code info: 1) DYNJ81325A, UDI-DI: 10195327270360(each), 40195327270361(case), Lot Number: 23HBB258