
Infant Breathing System Recall: AirLife/Vyaire Removes Infant Heated Wire Circuits Due to Risk for Inadvertent Adapter Disconnection During Ventilation
The FDA is aware that on April 10, 2025, AirLife and legal manufacturer Vyaire sent all affected customers an Urgent Medical Device Recall letter for certain Infant Heated Wire Circuits due to the risk that accessory adapters provided with the product may unintentionally disconnect during setup or use when the circuit reaches operating temperature. Use of the affected product may cause serious adverse health consequences, including lack of oxygen to the body (hypoxia), carbon dioxide build-up in the blood (hypercapnia), organ failure and death.
At this time, AirLife and Vyalire have reported no serious injuries and no deaths associated with this issue.
This recall involves removing certain devices from where they are used or sold. The U.S. Food and Drug Administration (FDA) has identified this recall as a Class I recall, the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with questions about this recall should contact AirLife at 1-800-433-2797 or productquality@myairlife.com.
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