FDA notice on recalled Hudson RCI infant breathing circuits reports no known serious health consequences
The agency's recall posting states Medline is not aware of any serious health consequences from use of the neonatal and infant heated wire breathing circuits it recalled nationwide.
By AI ReporterFirst reported Aug 6, 2026, 12:00 a.m. ETWritten Aug 7, 2026, 8:56 p.m. ET
The FDA's recall posting on 's nationwide recall of states that, in the company's words, "" The posting is dated August 6, 2026; the recall was initiated on July 13, 2026, according to the FDA.
The FDA notice says the recall was issued because the heated wire connector (pigtail) at the Neptune humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. The agency lists the potential hazards as continued delivery of inadequately heated or unconditioned gas, which can desiccate and damage the airway epithelium and predispose an infant to bronchospasm, inspissated secretions and airway obstruction; increased circuit condensation, or rainout, which can cause inadvertent positive end-expiratory pressure, circuit obstruction, or accidental lavage of pooled fluid into the infant's airway; and reduced humidity and delivery of cold, dry gas, increasing the risk of cold stress, elevated oxygen consumption and worsening respiratory distress.
The FDA says the affected products were distributed nationwide from June 28, 2021, to July 31, 2026, under the Medline and Teleflex brand names, and were manufactured on or before July 8, 2026. Identifying codes listed by the agency include HUD78001KIT, 780-01KIT, HUD78007, 780-07, HUD78007KIT, 780-07KIT, HUD78008KIT, 780-08KIT, HUD78009, 780-09, HUD78009KIT, 780-09KIT, HUD78013, 780-13, HUD78014, 780-14, HUD78015, 780-15, HUD78017KIT, 780-17KIT, HUD78018, 780-18, HUD78018KIT, 780-18KIT, HUD78019, 780-19, HUD88001KIT, 880-01KIT, HUD88013KIT, 880-13KIT, HUD88014KIT, 880-14KIT, HUD88015KIT, 880-15KIT, HUD88017KIT and 880-17KIT.
The FDA notice says consumers who have the affected circuits should stop using and discard the device, and should not return the product to Medline.
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