Medline Convenience Kits: 1) Ppe Kit, Model Number: Dyk1011945p

Recall Summary Medline is recalling PPE Kit Model DYK1011945P because equipment used to sterilize and package the kits had calibration problems. While the kits went through sterilization and packaging, the calibration issues could affect whether the products maintain their required sterility standards. This is a Class II recall affecting all units of this model.

Product

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

Reason

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.

Classification

Class II

Category

consumer product recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-01-07

Status

Open, Classified

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/ebe6375b-7f64-47d0-a2b6-37bba73247ab