Medline Industries recalled 753 tracheostomy kits on January 7, 2026, due to calibration issues in sterilization equipment. The defect may compromise the sterility assurance level of the devices. Users should stop using these products immediately and follow the recall instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter
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The recall includes three models: KIT STC TRACHEOSTOMY, Model Number DYKMBNDL55; KIT STC TRACHEOSTOMY, Model Number DYKMBNDL55A; and TRACH TOTE, Model Number DYNJ85691. These products were distributed worldwide, including across the United States.
Calibration issues with sterilization equipment could potentially compromise the sterility assurance level (SAL) of the recalled products. Without proper sterilization, there is an increased risk of infection for patients using these devices.
No incidents of injury or death have been reported in connection with this recall. However, the potential risk associated with compromised sterility remains a serious concern.
Stop using the recalled tracheostomy kits immediately. Contact Medline Industries for further instructions and to arrange for a refund.
For more information, contact Medline Industries, LP at their official website or customer service line. Notifications were sent to affected users via letter.
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