Medline Convenience Kits: 1) Baptist Floyd Endo Gi Kit, Model Number: Dyke1455b; 2) Gi Lab Other Endo Kit, Model Number: Dyke1721

Medline Convenience Kits Recall Summary Medline is recalling two medical convenience kits (Baptist Floyd Endo GI Kit, Model DYKE1455B, and GI Lab Other Endo Kit, Model DYKE1721) due to calibration problems with the equipment used to sterilize and package them. The calibration issues may have reduced the sterility assurance of these products, meaning they may not be as sterile as intended. This recall affects all units of these two kits that were processed through the affected sterilization equipment.

Product

Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721

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/26576845-91a7-4d79-8f3c-7715adebb325