Medline Industries, LP Issues Nationwide Recall of Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits

Medline Industries has issued a nationwide recall of Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits. These circuits are used to support the breathing of newborn and infant patients on a humidified ventilator.

Medline received reports of sporadic failures involving the electrical connector on these circuits. In affected circuits, the heated wire connector (pigtail) at the Neptune humidifier may show discoloration, melting, smoke, a burning odor, or other signs of localized thermal damage. The company reports these events have occurred infrequently relative to the number of devices distributed, at an observed occurrence rate of 0.011%.

The humidifier is designed to monitor the heated wire circuit and automatically cut power to the heated wires when it detects an electrical abnormality, and respiratory gas flow to the patient continues when that happens. However, gas that is no longer properly heated and humidified can dry out and damage an infant's airway, and can lead to condensation in the circuit, airway obstruction, and cold stress with worsening respiratory distress.

The recall notice states that consumers who have the affected circuits should stop using and discard the device, and should not return the product to Medline. Affected circuits can be identified by their product labeling, which carries the device name, item number, and manufacturing date; those made before January 2024 display a Teleflex label and item number, while those made from January 2024 onward display a Medline label and item number. Product manufactured on or after July 9, 2026 is not within the scope of the recall. Medline states that it is not aware of any serious health consequences that have occurred due to use of the device, and advises anyone who has experienced a problem that may be related to this device to contact their physician or healthcare provider.