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Medium risk Medical DevicesClass II

Medline PPE Kit Model DYK1011945P Recall

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

Updated January 7, 2026

Medline Convenience Kits PPE Kit (Model DYK1011945P) may not be properly sterilized due to calibration issues with the sterilization equipment. This could compromise the sterility assurance of the product.

Is the Medline Industries, LP recalled? Yes. This product was recalled by FDA on January 7, 2026. Details below.

What is recalled

Medline Convenience Kits: PPE Kit, Model Number DYK1011945P

Am I affected

You're affected if you have the Medline Convenience Kits PPE Kit with Model Number DYK1011945P.

What to do right now

Stop using this product immediately. Contact Medline Industries, LP for instructions on return or replacement.

The hazard

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.

Brands affected

Medline Industries, LP
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2104-2026
Classification
Class II
Recalled
January 7, 2026
Read the official notice

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