Medline Convenience Kits: 1) Hysteroscopy, Model Number: Cds984086i; 2) Kit Gyn Oncology Lap, Model Number: Dykmbndl91a; 3) Vaginal Hysterectomy Pack-lf, Model Number: Dynj0373807j; 4) Vaginal

Recall Summary Medline is recalling 36 gynecological and surgical convenience kits used in hospitals and medical facilities because equipment used to sterilize and package these kits may not have been properly calibrated. While all products went through sterilization processes, the calibration problems could affect whether the products maintain their sterility. These kits are used for procedures including hysterectomies, hysteroscopies, and other gynecological surgeries.

Product

Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R; 6) VAG HYST PACK, Model Number: DYNJ31344J; 7) VAG HYST PACK, Model Number: DYNJ31344K; 8) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L; 9) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M; 10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N; 11) RRMC VAGINAL HYSTERECTOMY...

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/45a0d6b8-9260-465c-95d0-eb3b415ba19f