Medline Convenience Kits: 1) Drape Pack-choice, Model Number: Dynj63118a

Recall Summary Medline is recalling Drape Pack-Choice kits (Model DYNJ63118A) because equipment used to sterilize and package these products had calibration issues that may have affected whether the products are properly sterilized. All affected products went through sterilization and packaging, but the calibration problems mean the sterility of these kits cannot be guaranteed.

Product

Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A

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/81a2fda1-1a2e-461e-ade0-eed9265e2bcc