FDA Enforcement
Class II
Ongoing
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
Recall: Z-2119-2026
·
Reported May 13, 2026
Enforcement
- Recall Number
- Z-2119-2026
- Event ID
- 98642
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medline Industries, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 13, 2026
- Initiation Date
- January 7, 2026
- Classification Date
- May 7, 2026
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
Description
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
Reason
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.
Code Info
1) DYNJ50806L, UDI-DI: 10195327344672(each), 40195327344673(case), Lot Number: 23FBK937
Distribution
Worldwide - US Nationwide distribution.
Quantity
32 units