Medline Convenience Kits: 1) Lithotomy Pack, Model Number: Dynj83185; 2) Lithotomy Pack, Model Number: Dynj83185a;

Recall Summary Medline is recalling two models of Lithotomy Packs (DYNJ83185 and DYNJ83185A) due to calibration problems with the sterilization and packaging equipment used to prepare them. While the products went through sterilization processes, the calibration issues could have affected whether the devices are actually sterile. This recall affects all Lithotomy Packs of these models that were produced with this equipment.

Product

Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A;

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/2df8cab1-d84d-4a36-899f-889bbf7c3977