Medline Convenience Kits: 1) Bap North Robotic Surgery Cds, Model Number: Cds982407n; 2) Tot/ Gyn Lithotomy Cds, Model Number: Cds985431k; 3) Tot/ Gyn Lithotomy Cds, Model Number: Cds985431o; 4

Medline Convenience Kits Recall Summary Medline is recalling multiple surgical convenience kits used in gynecological, urological, and robotic procedures due to calibration problems with the sterilization and packaging equipment. The calibration issues may have affected whether the kits were properly sterilized, though all products did go through sterilization cycles. The recall affects healthcare facilities that received these kits and includes 31 different model numbers across various surgical pack types.

Product

Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O; 4) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A; 5) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116A; 6) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116G; 7) ROBOTIC PACK, Model Number: DYNJ04135B; 8) MINOR LITHOTOMY PACK, Model Number: DYNJ04382J; 9) NBMC D & C PACK-LF, Model Number: DYNJ0665843C; 10) D&C PACK-LF, Model Number: DYNJ22567G; 11) D&C PACK-LF, Model Number: DYNJ22567J;...

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/c2d4ff4d-e8a2-4cc6-8df8-1812347a6fb1