Device recall

Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A

FDA recall source

Recall number

Z-0189-2027

Event id

99983

Status

Ongoing

FDA classification

Class II

Recalling firm

Medline Industries, LP

Report date

Oct 21, 2026

Posted

Oct 15, 2026

Initiated

Sep 11, 2026

Center classification date

Oct 15, 2026

Product code

KCY

Device type

Tourniquet, Pneumatic

Reason

Discrepancy in the shelf-life of a component

Root cause

Labeling Change Control

Quantity

30 kits

Code info

UDI/DI 10195327174156 (each) 40195327174157 (case), Lot Number 22GBW912

Distribution

US Nationwide distribution in the state of NY.

Voluntary or mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States