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-1407-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2026-01-07
Reported
2026-02-25
Distribution
Worldwide distribution - US Nationwide.
Code Info
1) DYNDM1031A, UDI-DI: 10884389555897(each), 40884389555898(case), Lot Number: 23EBM150
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.