Device recall
Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit. Respiratory gas humidifier.
- Recall number
- Z-2991-2026
- Event id
- 99403
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Medline Industries, LP
- Report date
- Sep 2, 2026
- Posted
- Aug 21, 2026
- Initiated
- Jul 13, 2026
- Center classification date
- Aug 21, 2026
- Product code
- BTT
- Device type
- Humidifier, Respiratory Gas, (Direct Patient Interface)
- 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
- Quantity
- 20 units
- Code info
- All lot codes
- Distribution
- Worldwide distribution - US Nationwide and the country of Panama.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K031383
- Location
- Northfield, IL, United States