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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Tracheostomy kits are medical devices used to assist patients with breathing difficulties by providing an airway. These kits are utilized in hospitals and home care settings by patients requiring respiratory support.
The recall stems from calibration issues in the sterilization process, which could lead to a lack of sterility in the devices. This raises the risk of infection for users.
This recall is not part of a broader industry pattern.
The recall may lead to significant health risks for users if devices are used without proper sterility. Patients and healthcare providers must act quickly to ensure safety.
Model numbers and lot numbers can typically be found on the product packaging or in accompanying documentation.
Expect a timeline of 4-6 weeks for processing your refund or replacement once the product is returned.
Keep copies of all correspondence with Medline, receipts of purchase, and any records of communications regarding the recall.
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.
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