← FDA ENFORCEMENT
Z-1841-2026Class 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
2026-04-29
Distribution
US Nationwide distribution.
Firm state
IL
Product quantity
36 units
Initiated by
Voluntary: Firm initiated
Reason for recall

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Product description

Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D

Code / lot info

1) DYNJ66777D, UDI-DI: 10195327365196(each), 40195327365197(case), Lot Number: 24JBX593

Other recalls SPEQ maps to Documentation & Change Control
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 →