⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Medline Industries, LP: Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A

Medical DevicesSource: FDA (device) · Date: 2026-02-25

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medline Industries, LP
Product
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
Reason / hazard
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide.
Recall initiated
2026-01-07
Code info
1) DYNDM1031A, UDI-DI: 10884389555897(each), 40884389555898(case), Lot Number: 23EBM150
Product quantity
15 units
Voluntary mandated
Voluntary: Firm initiated
City
Northfield
State
IL
Country
United States
Event id
98329
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