FDA closes recall of Medline neonatal heated breathing circuits

The agency has closed the Class II recall of Medline Hudson RCI heated wire breathing circuits, citing completion of the corrective action.

2 reports on this incident · first at Sep 7, 2026, 8:41 p.m. ET

By AI ReporterWritten Sep 7, 2026, 8:54 p.m. ET

The U.S. Food and Drug Administration has closed the recall of Medline Hudson RCI heated wire breathing circuits, recall number , according to an FDA enforcement report dated September 2, 2026. The agency considers the recall carried out, meaning the firm has completed the corrective action. The recall, initiated July 13, 2026, covers Medline Hudson RCI DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19), all lot codes. The product is a neonatal inspiratory heated-wire breathing circuit used in healthcare settings. The FDA classified the action as , its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The reason for the recall was that the heated wire connector at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage, which could predispose an infant to airway obstruction, inadvertent positive end-expiratory pressure, or other respiratory complications. The recall affected distributed in the U.S. and Panama. , of , Illinois, initiated the recall. The FDA database records no other enforcement action by this firm.

Earlier reports

Sep 7, 2026, 8:41 p.m. ETFirst report
Medline recalls neonatal heated breathing circuits over thermal damage risk
Medline Industries, LP, of Northfield, Illinois, initiated a recall of its Hudson RCI heated inspiratory ventilator breathing circuits, according to an FDA enforcement report dated September 2, 2026. The recall, identified as Z-2991-2026, affects 20 units distributed nationwide and in Panama. The product is identified as Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, with SKU HUD78019 (Teleflex SKU 780-19), all lot codes.
The FDA classified the recall as Class II, its middle category, indicating the product may cause temporary or medically reversible harm and that the chance of serious harm is remote. The agency states that the heated wire connector at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Such failure could predispose infants to bronchospasm, inspissated secretions, airway obstruction, inadvertent positive end-expiratory pressure, circuit obstruction, or accidental lavage of pooled fluid into the airway, as well as elevated oxygen consumption and worsening respiratory distress.
The recall was initiated on July 13, 2026, and is ongoing. The FDA enforcement report lists no other enforcement actions by Medline Industries in its database.

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Version 18 Sept 2026, 00:41current
First published.
Version 18 Sept 2026, 00:54current
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