Class II

Medical Device Recall: Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P

Medline Industries, LP · January 7, 2026

Reason for Recall

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.

Distribution

Worldwide distribution - US Nationwide.

States Affected

NATIONWIDE

Quantity Affected

7575 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1408-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.