Medline Convenience Kits: 1) Chest/breast-lf, Model Number: Dynj83950

Medline Convenience Kits Recall Summary Medline is recalling Chest/Breast-LF Convenience Kits (Model DYNJ83950) because calibration problems with the sterilization and packaging equipment may have affected the sterility of these products. While the kits went through sterilization and packaging processes, the equipment calibration issues mean they may not meet required sterility standards. This recall affects all units of this model that were processed with the affected equipment.

Product

Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950

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/c610809c-6ed9-493f-9ed1-ef96b4518e4f