Medline Convenience Kits: 1) Drawer 6-iv Fluids Gloves, Model Number: Acc010326; 2) Drawer 6-iv Fluids Gloves, Model Number: Acc010326a; 3) Drawer #5, Model Number: Acc010475; 4) Drawer 1 Neuro

Recall Summary Medline is recalling numerous surgical kits and convenience drawers used in hospitals because of calibration problems with the sterilization and packaging equipment. While these products went through sterilization processes, the equipment calibration issues could have affected whether the products are properly sterilized. This recall affects healthcare facilities that received these kits, which are used for various surgical procedures including organ transplants, cardiac surgery, orthopedic surgery, and other medical procedures.

Product

Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER #5, Model Number: ACC010475; 4) DRAWER 1 NEURO CART, Model Number: ACC010542; 5) DRAWER 2 NEURO CART, Model Number: ACC010543; 6) DRAWER 4, Model Number: ACC010722; 7) MALIGNANT HYPERTHERMIA CART, Model Number: ACC010896; 8) LIVER TRANSPLANT #57 CDS-2, Model Number: CDS860063U; 9) THOROCOTOMY CDS #24-RF, Model Number: CDS860066T; 10) CYSTO, Model Number: CDS981795G; 11) MAJOR PROCEDURE CDS, Model Number: CDS982414N; 12) TOTAL KNEE CDS, 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 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/28862cd9-78e7-4614-b938-5a37ef6fa1b0