The nationwide recall affects Hudson RCI neonatal and infant heated wire breathing circuits following reports of melting, smoke, and localized thermal damage at the humidifier connector.
Medline Industries has initiated a nationwide recall of Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits due to reports of electrical connector failures. The recall involves the heated wire connector, or pigtail, at the Neptune humidifier, which may exhibit discoloration, melting, smoke, a burning odor, or other signs of localized thermal damage.
The Neptune humidifier features safety mechanisms designed to monitor the heated wire circuit and automatically stop power to the wires if electrical abnormalities are detected. While gas flow to the patient continues when power is disconnected, the loss of heating function can lead to clinical complications.
According to the company, the delivery of inadequately heated or unconditioned gas can damage the airway epithelium, potentially leading to bronchospasm, thickened secretions, and airway obstruction in infants. Furthermore, the loss of heated wire function may cause increased circuit condensation, also known as rainout. This condensation can result in inadvertent positive end-expiratory pressure, circuit obstruction, or the accidental entry of fluid into the patient’s airway.
The affected products were manufactured on or before July 8, 2026, and distributed between June 28, 2021, and July 31, 2026. Medline Industries reports that failures have occurred infrequently, with an observed occurrence rate of 0.011% across the distributed population.
Healthcare providers can identify the recalled circuits by checking the product labeling for specific item numbers and manufacturing dates. Products manufactured before January 2024 feature a Teleflex label and item number, while those manufactured from January 2024 onward carry a Medline label and item number.
Medline Industries is instructing healthcare facilities to stop using the affected Hudson RCI circuits and discard them immediately. The company is notifying distributors and customers by email and mail to arrange for credit for the recalled units.
“Medline voluntarily recalled product after thorough investigation of reports received for this issue and notified the FDA of this action,” reads a release from Medline Industries.
At this time, the company is not aware of any serious health consequences related to the use of these devices. Consumers with questions can contact the company at 866-359-1704 or via email at [email protected]. Adverse reactions or quality problems may also be reported to the Food and Drug Administration MedWatch program.
