Medline Convenience Kits: 1) Ob Kit, Model Number: Dykm2326; 2) Kit Labor Delivery Tubal Ligat, Model Number: Dykmbndl165; 3) Kit Labor & Delivery D&c/d&e, Model Number: Dykmbndl31; 4) Kit Labo

Recall Summary Medline is recalling 52 models of obstetric and gynecological convenience kits used in labor, delivery, and surgical procedures. The equipment used to sterilize and package these kits had calibration problems that could affect whether the products maintain their sterile condition, even though they went through the standard sterilization process. These kits were distributed to healthcare facilities.

Product

Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) L & D PACK-LF, Model Number: DYNJ0456816O; 6) L & D PACK-LF, Model Number: DYNJ0456816P; 7) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ04692S; 8) VAGINAL DELIVERY PACK, Model Number: DYNJ16621B; 9) VAGINAL DELIVERY PACK, Model Number: DYNJ16621C; 10) DELIVERY PACK-LF, Model Number: DYNJ20546F; 11) VAGINAL DELIVERY PK, Model Number: DYNJ20979I; 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/cde1733a-6f49-4b96-b008-44947eb02d65