FDA Enforcement
Class II
Ongoing
Sterile Radiology Procedure Kits, Model Number DYNDH1491B
Recall: Z-1693-2026
·
Reported April 8, 2026
Enforcement
- Recall Number
- Z-1693-2026
- Event ID
- 98529
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medline Industries, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 8, 2026
- Initiation Date
- February 18, 2026
- Classification Date
- March 27, 2026
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
Description
Sterile Radiology Procedure Kits, Model Number DYNDH1491B
Reason
There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.
Code Info
UDI-DI: (CS) 40198459071455, (EA) 10198459071454; Lot Number: 25GBB924
Distribution
US Nationwide distribution in the state of MN.
Quantity
420 units