Medline Convenience Kits: 1) Robotic Gyn Cds-1, Model Number: Cds982893i; 2) Gyn Laparoscopy Cds, Model Number: Cds983300j; 3) Nhp Robotic Gyne Cds, Model Number: Cds984243g; 4) Robotic-lf, Mod

Medline is recalling multiple surgical convenience kits used in gynecological, urological, and other surgical procedures due to calibration problems with the sterilization and packaging equipment. The calibration issues may have compromised the sterility of these kits, meaning they may not be properly sterilized. This recall affects healthcare facilities that received these kits.

Product

Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 3) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 4) ROBOTIC-LF, Model Number: CDS984543D; 5) ROBOTIC-LF, Model Number: CDS984543F; 6) ROBOTIC-LF, Model Number: CDS984543G; 7) ROBOTIC-LF, Model Number: CDS984543I; 8) GYN CDS, Model Number: CDS984860F; 9) GYN LAP PELVI, Model Number: CDS985423G; 10) GYN KIT, Model Number: DYKM1657A; 11) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL100; 12) KIT ROBOTICS GYN, Model Number: DYKMBNDL109; 13) KIT ROBOTICS UROLOGY PROSTATE,...

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/41b9475a-1798-40d2-bc73-3fb7d206f2d4