Device recall

Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330

FDA recall source

Recall number

Z-2999-2026

Event id

99506

Status

Ongoing

FDA classification

Class II

Recalling firm

Medline Industries, LP

Report date

Sep 2, 2026

Posted

Aug 21, 2026

Initiated

Jul 10, 2026

Center classification date

Aug 21, 2026

Product code

OFR

Device type

Tracheobronchial Suction Catheter Kit

Reason

Component labeling discrepancy

Root cause

Labeling Change Control

Quantity

45 kits

Code info

UDI/DI 10198459582158 (each) 40198459582159 (case), Lot Number 26FLA408

Distribution

US Nationwide distribution in the state of California.

Voluntary or mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States