Medline Convenience Kits: 1) Plastic Bin W/misc Kits, Model Number: Acc010499; 2) Kit Urology Urethroplasty, Model Number: Dykmbndl117c; 3) Kit Plastic Insert Tissue Expa, Model Number: Dykmbndl1

Recall Summary Medline is recalling multiple surgical convenience kits used in hospitals and surgical centers because equipment used to sterilize and package these kits may not have been properly calibrated. This means the products may not have been sterilized to the required standards, even though they went through sterilization processes. The recall affects dozens of different surgical kit models used for procedures including breast surgery, plastic surgery, and other surgical specialties.

Product

Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158; 4) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170; 5) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170A; 6) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170B; 7) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182; 8) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182A; 9) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182B; 10) KIT PLASTIC ROTATIONAL FLAP, Model...

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/885cb2be-ff68-4e20-a855-8139f601a197