Medline has identified issues related to calibration of the equipment used to sterilize and package the devices
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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.
Recall Number
Z-1406-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2026-01-07
Reported
2026-02-25
Distribution
Worldwide distribution - US Nationwide.
Code Info
1) DYNJ63118A, UDI-DI: 10195327644291(each), 40195327644292(case), Lot Number: 25ABV005
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.