Medline Industries, LP Issues Nationwide Recall of Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits
On July 13, 2026, Medline Industries, LP initiated a nationwide recall of Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits. Medline received reports of sporadic failures involving the electrical connector of certain neonatal and infant heated wire breathing circuits. In affected circuits, the heated wire connector (pigtail) at the Neptune humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. To date, reported events have occurred infrequently relative to the number of devices distributed, with the observed occurrence rate of 0.011% across the distributed population. Refer to the below photographs of the product and a defect that was reported to Medline.
The Neptune humidifier is designed with safety features that continually monitor the heated wire circuit and automatically discontinues power to the heated wires when electrical abnormalities are detected. When power to the heated wires is disconnected, respiratory gas flow to the patient continues. The disconnection of power is limited to the heated wire function.
Continued delivery of inadequately heated or unconditioned gas can desiccate and damage the airway epithelium, predisposing the infant to bronchospasm, inspissated secretions, and airway obstruction. Potential continued loss of heated wire function may result in increased circuit condensation (rainout), which can cause inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the infant’s airway, reduced humidity and delivery of cold, dry gas increases the risk of cold stress, leading to elevated oxygen consumption and worsening respiratory distress.
Consumers who have the affected Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits should stop using and discard the device. Consumers should not return product to Medline.
Medline voluntarily recalled product after thorough investigation of reports received for this issue and notified the FDA of this action. At this time, Medline is not aware of any serious health consequences which have occurred due to use of the device.