Medline Convenience Kits: 1) Kit Surg Onc Excision Breast, Model Number: Dykmbndl84a; 2) Kit Surg Onc Exploratory Lap, Model Number: Dykmbndl87a; 3) Ct Biopsy Tray, Model Number: Dyndh1143c; 4)

Medline Convenience Kits Recall Summary Medline is recalling 10 surgical and biopsy kit products used in medical procedures because calibration problems with the sterilization and packaging equipment may have affected whether these kits were properly sterilized. While all products went through sterilization processes, the equipment calibration issues could have compromised the sterility of the recalled kits. The recall affects multiple breast surgery, exploratory surgery, and biopsy products with various model numbers.

Product

Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number: DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number: DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number: DYNDH1873; 5) BIOPSY SPECIALS PACK, Model Number: DYNDH1934; 6) BREAST BIOPSY PACK, Model Number: DYNJ17489I; 7) VOR PACK-LF, Model Number: DYNJ48539; 8) VOR PACK-LF, Model Number: DYNJ48539A; 9) IR BIOPSY PACK, Model Number: DYNJ59897B; 10) BREAST PACK, Model Number: DYNJ82998

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/ac76289a-cce7-4d9f-86c9-f1b4d62469a4