Medline Convenience Kits: 1) Tote Abrams Knee Arthroscopy, Model Number: Dykm1801b; 2) Tote Sen Osc Hand Repair, Model Number: Dykm1776; 3) Tote Momeni Sb Capsulotomy Rec, Model Number: Dykm1765a

Medline Convenience Kits Recall Summary Medline is recalling 16 surgical convenience kits used in orthopedic and general surgical procedures due to calibration problems with the sterilization and packaging equipment. The calibration issues mean the sterility assurance of these kits may have been compromised, even though they went through sterilization cycles. The recall affects healthcare facilities that received these kits, which are identified by specific model numbers ranging from DYKM1756A to CVI4500A.

Product

Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Model Number: DYKM1776; 3) TOTE MOMENI SB CAPSULOTOMY REC, Model Number: DYKM1765A; 4) TOTE YAO OSC HAND REPAIR, Model Number: DYKM1796A; 5) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 6) TOTE FOX OSC HAND REPAIR, Model Number: DYKM1783A; 7) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 8) TOTE SB NGUYEN LIPOSUCTION, Model Number: DYKM1927A; 9) TOTE YAO OSC WRIST ARTHROSCOPY, Model Number: DYKM1807; 10) TOTE CURTIN OSC HAND REPAIR, Model Number: DYKM1781A; 11)...

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/1109d6ac-460b-433d-99c7-502216748680