Recall Z-2991-2026 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Medline Industries, LP
Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit
| Date | Aug 21, 2026 (initiated Jul 13, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Medline issued an Urgent Medical Device notice it its consignees on 7/13/2026 via email and USPS. The notice explained the issue, potential risk, and provided actions and precautions for healthcare providers. If evidence of connector overheating or thermal damage is observed: " Assess the patient and ensure continued respiratory support. " Replace the affected circuit as soon as clinically appropriate. " Remove the affected circuit from service and retain it for investigation." For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. Follow up notice sent on |
| Quantity | 20 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Panama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031383 | MODEL 780 Hudson Respiratory Care, Inc., Jul 7, 2003 |