The devices may have cracks that could lead to patient rebreathing of exhaled gases.
Hamilton Medical is recalling certain lots of its coaxial breathing circuit sets used with its ventilators after a manufacturing defect was found to pose a risk of serious injury or death to patients. The US Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type. This recall involves removing certain devices from where they are used or sold.
According to the FDA notice, the recall was initiated due to a quality issue involving a defective blade used during the tube-cutting stage of production. The blade may cause a crack in the circuit’s inner blue limb, which is responsible for delivering fresh gas to the patient, while the outer limb carries away exhaled gas.
If a crack compromises the inner tube, the separation between inspiratory and expiratory gas flows can be lost, leading to partial or complete rebreathing of exhaled gases. The FDA warns this can cause an acute buildup of carbon dioxide, known as hypercapnia, and respiratory acidosis. If the problem goes unrecognized, it could lead to organ dysfunction and death. To date, no injuries or deaths related to this issue have been reported.
The affected coaxial breathing circuits are designed for use with Hamilton Medical’s HAMILTON-C1/T1/MR1 ventilators, connecting the device to a patient’s endotracheal tube or respiratory mask.
On June 27, 2025, the company sent an Urgent Medical Device Recall notice to all affected customers. The notice instructs users to stop using any breathing circuits from affected lots, replace any currently in use with patients, and discard the affected products. Customers in the US with questions about the recall can contact Hamilton Medical, Inc at 800-426-6331.
