← FDA ENFORCEMENT
Z-1693-2026Class 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
2026-04-08
Distribution
US Nationwide distribution in the state of MN.
Firm state
IL
Product quantity
420 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.

Product description

Sterile Radiology Procedure Kits, Model Number DYNDH1491B

Code / lot info

UDI-DI: (CS) 40198459071455, (EA) 10198459071454; Lot Number: 25GBB924

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring 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 →