FDA Enforcement
Class II
Ongoing
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Recall: Z-1406-2026
·
Reported February 25, 2026
Enforcement
- Recall Number
- Z-1406-2026
- Event ID
- 98329
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medline Industries, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 25, 2026
- Initiation Date
- January 7, 2026
- Classification Date
- February 17, 2026
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
Description
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
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) DYNJ63118A, UDI-DI: 10195327644291(each), 40195327644292(case), Lot Number: 25ABV005
Distribution
Worldwide distribution - US Nationwide.
Quantity
72 units