Device recall

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

FDA recall source

Recall number

Z-3266-2026

Event id

99739

Status

Ongoing

FDA classification

Class II

Recalling firm

Medline Industries, LP

Report date

Sep 30, 2026

Posted

Sep 24, 2026

Initiated

Aug 10, 2026

Center classification date

Sep 24, 2026

Product code

FDE

Device type

Laparoscopy Kit

Reason

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.

Root cause

Nonconforming Material/Component

Quantity

128 kits

Code info

1) DYNJ81325A, UDI-DI: 10195327270360(each), 40195327270361(case), Lot Number: 23HBB258

Distribution

US Nationwide.

Voluntary or mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States