AirLife, in coordination with legal manufacturer Vyaire Medical, has issued an urgent Class I recall of specific AirLife Infant Heated Wire Circuits following reports of potential inadvertent disconnection of accessory adapters during ventilation. This FDA-designated Class I recall—the most serious type—indicates that continued use of the affected devices may lead to serious injury or death.
The recall involves dual-limb, dual-heat, high-flow infant heated wire circuits (>4L/min) distributed under both AirLife and Vyaire labels, including the AH165 model. The adapters, provided in the accessory bags of these circuits, may disconnect during operation as the device reaches operating temperature, risking ventilation failure in neonatal and infant patients.
Products under recall include:
AirLife Infant Heated Wire Circuit – AH165
AirLife Infant Heated Wire Circuit Kit – AH290 Chamber/AH265
Complete UDI and case lot information is provided in the detailed recall notice. The issue specifically concerns accessory adapters included with these models.
The use of affected circuits with the faulty adapters may result in hypoxia, hypercapnia, respiratory distress, organ failure, and potentially fatal outcomes. While no serious injuries or deaths have been reported to date, the risk is considered critical given the vulnerability of the neonatal population.
On April 10, 2025, AirLife and Vyaire began notifying all affected customers via an Urgent Medical Device Recall letter. Key recommended actions include:
Immediate cessation of use for circuits using the recalled adapters.
Quarantining affected stock and notifying internal teams and consignees.
Monitoring ventilator circuits closely, ensuring pressure alarms and disconnection alarms are fully activated.
Keeping emergency backup ventilation/resuscitation devices bedside.
Testing all circuits before use, including pressure testing to detect leaks.
Returning the provided response form and contacting AirLife directly at 1-800-433-2797 for urgent replacement needs.
