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FDA closes recall of Medline neonatal breathing circuits

The agency has closed the Class II recall of certain heated wire breathing circuits distributed by Medline Industries, LP.

2 reports on this incident · first at Sep 7, 2026, 9:21 p.m. ET

By AI ReporterWritten Sep 7, 2026, 9:23 p.m. ET
The U.S. Food and Drug Administration has closed the recall of certain Medline neonatal and infant heated wire breathing circuits, according to an FDA enforcement report dated September 2, 2026. The agency considers the recall carried out. The recall, initiated July 13, 2026, was classified as , meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote, per FDA definitions. The affected products are breathing circuits labeled as Hudson RCI, with Medline product numbers HUD78007, HUD78009, 780-13, 780-14, 780-15, and HUD7801780-18 (also listed as 780-18). All lot numbers are included. The recall covers about 145,525 units distributed in the U.S. and Panama. The FDA reported that the circuits may experience sporadic failure of the heated wire connector, leading to discoloration, melting, smoke, or burning odor, which could predispose infants to airway obstruction or other respiratory complications. The FDA database records no other enforcement action by this firm.

Earlier reports

  1. Sep 7, 2026, 9:21 p.m. ETFirst report

    Medline recalls neonatal breathing circuits over risk of thermal damage

    Medline Industries, LP, of Northfield, Illinois, is recalling certain neonatal and infant heated wire breathing circuits, according to an FDA enforcement report dated September 2, 2026. The recall, initiated July 13, 2026, covers about 145,525 units distributed nationwide and in Panama. The FDA has classified the action as Class II, meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote.

    The affected products are sold under the Hudson RCI brand and include Medline product numbers HUD78007, HUD78009, 780-13, 780-14, 780-15, and HUD7801780-18 (Teleflex equivalents 780-07, 780-09, 780-13, 780-14, 780-15, and 780-18). All lot numbers are included. The FDA report states the heated wire connector at the humidifier may show discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Such failure could predispose an infant 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 is ongoing. The FDA database lists no other enforcement action by Medline Industries, LP. The FDA's recall notice does not specify a remedy; consumers should consult the notice or their supplier for instructions.

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Revision history

  1. Version 18 Sept 2026, 01:21current

    First published.

  2. Version 18 Sept 2026, 01:23current

    First published.

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