Medline Convenience Kits: 1) Major Laparotomy Cds, Model Number: Cds860015u; 2) Major Laparotomy Cds, Model Number: Cds860015v; 3) Major Laparotomy Cds, Model Number: Cds860015w; 4) Major Lapar

Recall Summary Medline is recalling 70 surgical convenience kits used in hospitals for various procedures, including laparotomy, laparoscopy, robotic surgery, and urology operations. The kits may not be properly sterilized due to calibration problems with the equipment used to sterilize and package them, which could affect their sterility. Healthcare facilities that received these kits should identify them by their model numbers and contact Medline for instructions.

Product

Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X; 5) MINOR LAPAROTOMY CDS, Model Number: CDS860016P; 6) MINOR LAPAROTOMY CDS, Model Number: CDS860016Q; 7) MINOR LAPAROTOMY CDS, Model Number: CDS860016R; 8) MINOR LAPAROTOMY CDS, Model Number: CDS860016S; 9) LAP GASTRIC BYPASS CDS, Model Number: CDS860146M; 10) NEW LONDON MINOR CDS, Model Number: CDS982518M; 11) NEW LONDON MINOR CDS, Model Number: CDS982518N; 12)...

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/b13763b3-1e08-4316-a294-934efcde55b5