AirLife/Vyaire Infant Breathing Systems Recall

Class I Recall

AirLife and manufacturer Vyaire are recalling specific Infant Heated Wire Circuits due to the risk that accessory adapters may disconnect during use, especially once the system reaches operating temperature. This could lead to serious injury or death, including hypoxia, hypercapnia, organ failure, and respiratory collapse.

The FDA has classified this as a Class I recall, the most serious type.

Device Use

These circuits are used to warm breathing gases during mechanical ventilation in neonatal and infant patients, connecting the ventilator to the airway.

Affected Products

• AirLife and Vyaire Infant Heated Wire Circuit AH165 and kits with AH265 chamber
• High-flow dual-limb, dual-heat systems (>4 L/min)
• Full UDI details are listed in the FDA’s Medical Device Recall Database

What You Should Do

• Do NOT use the accessory adapter connections from affected circuit kits.
• Stop using any devices currently using these adapters.
• Devices may still be used if adapter connections are not installed.
• Quarantine affected products, notify relevant staff, and perform regular system checks.
• Activate all ventilator alarms and monitor respiratory parameters closely.
• Ensure backup ventilation/resuscitation equipment is available at bedside.
• Test circuits before use for leaks.
• Return the completed Response Form and notify any customers who received the affected products.
• For urgent needs, call AirLife at 1-800-433-2797 or email: productquality@myairlife.com

This recall is a critical safety action to protect vulnerable infant patients from potential airway disconnection and respiratory failure. Prompt inventory review and staff notification are essential. 

Affected Products

Affected Lot Numbers