The Recall Desk

FDA (Devices) recall action 96664

Vyaire Medical recalled 2 products on 2025-05-21

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2025-05-21
Critical
0
Units
4,948

Why these products were recalled

Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • SevereFDA (Devices)··2025-05-21

    AirLife Infant Heated Wire Circuit Adapter Disconnection Risk

    Vyaire Medical is recalling the AirLife Infant Heated Wire Circuit (Model AH165) because adapters may disconnect during setup or use, interrupting ventilation to infants and potentially causing severe complications.

    Product
    Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min) Component: No. a conduit for respiratory gas bet
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2025-05-21

    AirLife Infant Heated Wire Circuit Adapter Disconnection Risk Recall

    Vyaire Medical is recalling the AirLife Infant Heated Wire Circuit (model AH265) because adapters may disconnect during setup or use, potentially interrupting ventilation to newborns. Disconnection can cause hypoxia, hypercapnia, and organ failure.

    Product
    Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, high-flow circuit (>4 L/min) Contains AH165 Circuit, AH290 Chamber Compone
    Category
    Distribution
    0 states