AirLife and medical device manufacturer Vyaire are recalling specific infant breathing support systems due to a potentially dangerous defect that could lead to serious injury or death. The recall,
classified by the U.S. Food and Drug Administration (FDA) as a Class I recall
, the most serious type, affects AirLife Infant Heated Wire Circuits used in neonatal and infant ventilation.
These circuits are designed to warm and deliver breathing gases from a ventilator to a patient. However, accessory adapters included in some of the affected products can unintentionally disconnect during setup or once the device reaches operating temperature. If the disconnection occurs during ventilation, it could result in reduced oxygen levels (hypoxia), increased carbon dioxide in the blood (hypercapnia), organ failure or even death.
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The recall involves dual-limb, dual-heat, high-flow circuits sold under both the AirLife and Vyaire brands, including model number AH165. Some affected products were also distributed in kit form, containing both the circuit and additional components such as the AH290 chamber. Each product includes a unique device identifier (UDI), which can be found on its packaging.
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Customers were first notified in an urgent recall letter sent on April 10, 2025. The letter instructed hospitals and healthcare providers to immediately examine their inventory, quarantine any affected products and alert relevant staff to the potential hazard. The recall applies specifically to devices using the accessory adapter from the product’s accessory bag. Providers are advised to discontinue use of the adapter immediately and only continue using the system if the adapter is not involved in the setup.
In addition to stopping use of the affected adapters, healthcare professionals are instructed to conduct frequent checks on ventilator settings and tubing connections, ensure alarm systems are functioning properly and have emergency backup ventilation or manual resuscitation devices readily available. Clinicians should closely monitor a patient’s oxygen saturation, heart rate and respiratory rate to ensure timely response to any issues.
Before using any circuit, providers should test the system by blocking the patient connection port and conducting a pressure test to detect any potential leaks.
As of now, no injuries or deaths related to this defect have been reported. However, due to the high risk posed by the potential disconnection, providers are urged to take immediate action.
Customers in the U.S. with questions or those in need of urgent replacement products should contact AirLife at 1-800-433-2797 or email
. Healthcare providers and consumers can also report adverse events or quality concerns related to this product through the FDA’s MedWatch reporting system.
