Device recall

Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991S

FDA recall source

Recall number

Z-3021-2026

Event id

99507

Status

Ongoing

FDA classification

Class II

Recalling firm

Medline Industries, LP

Report date

Sep 2, 2026

Posted

Aug 26, 2026

Initiated

Jul 10, 2026

Center classification date

Aug 26, 2026

Product code

OGR

Device type

Ear, Nose, And Throat Surgical Tray

Reason

Kits contain a potentially contaminated component which were recalled by the manufacturer

Root cause

Process change control

Quantity

24 kits

Code info

UDI/DI 10198459312557 (each) 40198459312558 (case), Lot Number 25LLA853

Distribution

US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.

Voluntary or mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States