Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55A; 3) TRACH TOTE, Model Number:DYNJ85691
Class II
- Recalling firm
- Medline Industries, LP
- Reason for recall
- 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.
- Distribution pattern
- Worldwide - US Nationwide distribution.
- State
- IL
- Status
- Ongoing
- Recall number
- Z-2115-2026
- Recall initiated
- January 7, 2026
View on openFDA