← FDA ENFORCEMENT
Z-2999-2026Class II
Medline Industries, LP
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Medline Industries, LP
Product type
Device
Status
Ongoing
Report date
2026-09-02
Distribution
US Nationwide distribution in the state of California.
Firm state
IL
Product quantity
45 kits
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change ControlReason for recall
Component labeling discrepancy
Product description
Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330
Code / lot info
UDI/DI 10198459582158 (each) 40198459582159 (case), Lot Number 26FLA408
Other recalls SPEQ maps to Documentation & Change Control
2026-09-02Class IIMidmark Corporation2026-09-02Class IIConMed Corporation2026-09-02Class IIAVID Medical, Inc.2026-09-02Class IIOlympus Corporation of the Americas
See all Documentation & Change Control recalls →Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →