Z-1693-2026 Class II Ongoing

Recalled by Medline Industries, LP — Northfield, IL

FDA device recall Z-1693-2026 was initiated by Medline Industries, LP on February 18, 2026 and is designated Class II. Reason for recall: There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility. The recall status is ongoing. Affected quantity: 420 units.

Recall Details

Product Type
Devices
Report Date
April 8, 2026
Initiation Date
February 18, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
420 units

Product Description

Sterile Radiology Procedure Kits, Model Number DYNDH1491B

Reason for Recall

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

Distribution Pattern

US Nationwide distribution in the state of MN.

Code Information

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