Medline Convenience Kits: 1) Kit General Closure, Model Number: Dykmbndl200a

Medline Convenience Kits Recall Summary Medline is recalling its Convenience Kit General Closure (Model DYKMBNDL200A) because equipment used to sterilize and package the kits had calibration problems that may have affected whether the products remained sterile. This is a Class I recall, meaning there is a potential serious adverse health consequence or death.

Product

Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A

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 I

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/aa90a142-9d64-4f34-8853-1b6b2c2abcb1