← FDA ENFORCEMENT
Z-1832-2026Class II

Medline Industries, LP

Recalling firm
Medline Industries, LP
Product type
Device
Status
Ongoing
Report date
2026-04-29
Distribution
US Nationwide distribution.
Firm state
IL
Product quantity
15 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D

Code / lot info

1) DYNJ24517D, UDI-DI: 10193489812510(each), 40193489812511(case), Lot Number: 25CBA224

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Data: U.S. FDA openFDA enforcement API. 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.