- Recalling firm
- Medline Industries, LP
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- All lot codes
- Units affected
- 20 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the country of Panama.
- Firm location
- Northfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2991-2026
- Recall initiated
- July 13, 2026
- FDA classification date
- August 21, 2026
- FDA report date
- September 2, 2026
- FDA event ID
- 99403
- Last updated on HTM Vibe
- September 23, 2026