FDA Reports No Serious Injuries in Ongoing Medline Breathing Circuit Recall

Medline's recall of Hudson RCI neonatal and infant heated wire breathing circuits continues as the FDA notes no serious injuries or deaths have been reported.

3 reports on this incident · first at Sep 7, 2026, 6:46 a.m. ET

By AI ReporterFirst reported Sep 1, 2026, 12:00 a.m. ETWritten Sep 7, 2026, 6:53 a.m. ET

The U.S. Food and Drug Administration (FDA) reports that, as of July 31, has not reported any serious injuries or deaths associated with the recall of . The recall, classified as Class II, was initiated due to sporadic failures involving the electrical connector of certain circuits, which can lead to inadequately heated or conditioned gas delivery, potentially causing airway damage in infants. has instructed users to immediately identify and quarantine affected products, and to destroy them after recall actions are complete. The affected products include a range of model numbers such as HUD78001KIT, 780-01KIT, and HUD78007. The FDA notice lists the remaining identifying codes. The recall remains as of the FDA's September 1, 2026, report.

Earlier reports

Sep 7, 2026, 6:51 a.m. ET
FDA Closes Recall of Medline Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits
The U.S. Food and Drug Administration has closed the recall of Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits distributed by Medline, according to an agency notice dated September 1, 2026. The closure means the FDA considers the recall action complete.
The recall, classified as Class II, was initiated after Medline received reports of sporadic failures involving the electrical connector of certain circuits. The FDA warned that continued delivery of inadequately heated or unconditioned gas can desiccate and damage the airway epithelium, predisposing infants to bronchospasm, inspissated secretions, and airway obstruction. As of July 31, Medline had not reported any serious injuries or deaths associated with the issue.
Affected product codes 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, HUD88013KIT, 880-13KIT, HUD88014KIT, 880-14KIT, HUD88015KIT, 880-15KIT, HUD88017KIT, and 880-17KIT.
The FDA instructed users to immediately identify and quarantine affected breathing circuits and to destroy affected product after recall actions are complete.
Sep 7, 2026, 6:46 a.m. ETFirst report
Medline Recalls Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits
Medline is recalling Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits, the U.S. Food and Drug Administration announced on September 1, 2026. The recall is classified as Class II and is ongoing.
The recall follows reports of sporadic failures involving the electrical connector of certain circuits. According to the FDA, continued delivery of inadequately heated or unconditioned gas can desiccate and damage the airway epithelium, predisposing infants to bronchospasm, inspissated secretions, and airway obstruction. As of July 31, Medline has not reported any serious injuries or deaths associated with this issue.
The affected products include model numbers such as HUD78001KIT, 780-01KIT, HUD78007, and others. Medline advises customers to immediately identify and quarantine affected circuits and to destroy the product after recall actions are complete.

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Sources

Medline Removes Neonatal and Infant Heated Wire Breathing Circuitsfda.gov

Revision history

Version 17 Sept 2026, 10:46current
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Version 17 Sept 2026, 10:53current
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