Medline Convenience Kits: 1) Dental Pack, Model Number: Dynda3003

Recall Summary Medline is recalling Dental Pack convenience kits (Model DYNDA3003) because equipment used to sterilize and package these products had calibration problems. While all products went through sterilization and packaging processes, the calibration issues could affect whether the products maintain their sterility. This is a Class I recall, the most serious classification.

Product

Medline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003

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/ecbb7e72-1d1e-40a6-bdc2-a1e1a3a0a5d1