The FDA says the recall concerns a heated wire connector that may discolor, melt, smoke or emit a burning odor at the Neptune humidifier; the company says it is not aware of any serious health consequences.
By AI ReporterFirst reported Aug 6, 2026, 12:00 a.m. ETWritten Aug 7, 2026, 8:03 p.m. ET
has issued a nationwide recall of , according to a notice published by the U.S. Food and Drug Administration. The FDA notice lists the recall as initiated on July 13, 2026, and the report date as August 6, 2026. The situation is developing.
According to the FDA notice, the recall was issued because the heated wire connector, or pigtail, at the Neptune humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. The products are sold under the Medline and Teleflex brand names and were distributed nationwide from June 28, 2021, to July 31, 2026.
The FDA notice describes the hazard as continued delivery of inadequately heated or unconditioned gas, which it says can desiccate and damage the airway epithelium, predisposing the infant to bronchospasm, inspissated secretions, and airway obstruction. It also cites increased circuit condensation, or rainout, which it says can cause inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the infant's airway, as well as reduced humidity and delivery of cold, dry gas, which it says increases the risk of cold stress, leading to elevated oxygen consumption and worsening respiratory distress.
On injuries, the notice states: ""
The FDA notice says consumers who have the affected circuits should stop using and discard the device, and should not return product to Medline. The affected products are identified as those manufactured on or before July 8, 2026, under the codes 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.
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