Medline Convenience Kits: 1) Kit Urology Sling, Model Number: Dykmbndl106; 2) Kit Urology Sling, Model Number: Dykmbndl106a; 3) Kit Urology Penile Repair, Model Number: Dykmbndl188; 4) Kit Urol

Recall Summary Medline is recalling five urology surgical kits (sling, penile repair, and peripheral stimulation models) because equipment used to sterilize and package them may not have been properly calibrated. While the products went through sterilization processes, the calibration problems could have affected whether the devices met required sterility standards. This is a Class II recall affecting medical facilities that received these kits.

Product

Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBNDL106A; 3) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188; 4) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189; 5) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189A

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/ba46384f-7bd5-4cc4-9348-d8022d5e31cd