Medline Hudson RCI neonatal breathing circuit recalled for heated wire connector failure risk
What this means
The heated wire connector in Medline Hudson RCI neonatal and infant breathing circuits may fail unpredictably, causing discoloration, melting, smoke, or burning. If the circuit fails, infants may experience airway obstruction, difficulty breathing, or fluid pooling in the airway.
- If you use this breathing circuit (Medline HUD78019 or Teleflex 780-19), stop using it immediately.
- Contact Medline Industries or your equipment supplier for replacement or instructions.
- Inspect the heated wire connector for discoloration, melting, smoke residue, or burning odor before each use.
- Monitor patients closely for signs of respiratory distress or unusual odors during device operation.
The agency's original wording
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2991-2026More Medline recalls
- FDA-Device2026-09-30Medline neurological surgical kits recalled for elevated endotoxin levels in sponges
- FDA-Device2026-09-30Medline Convenience Kits Major Pack recalled for elevated endotoxin levels in neurological sponges
- FDA-Device2026-09-30Medline Convenience Kits recalled for elevated endotoxin levels in sponges
- FDA-Device2026-09-30Medline sinus convenience kits recalled for sharp brush edges risking cut injury
- FDA-Device2026-09-30Medline surgical convenience kits recalled for elevated endotoxin levels in neurological sponges
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.