Medline has identified issues related to calibration of the equipment used to sterilize and package the devices
Advertisement
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-1404-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2026-01-07
Reported
2026-02-25
Distribution
Worldwide distribution - US Nationwide.
Code Info
1) DYNJ15668R, UDI-DI: 10195327108502(each), 40195327108503(case), Lot Number: 23HMB037; 2) DYNJ42829B, UDI-DI: 10193489880151(each), 40193489880152(case), Lot Number: 22IBI084; 3) DYNJT3437, UDI-DI: 10198459325076(each), 40198459325077(case), Lot Number: 25FBK633
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.