Fisher & Paykel Healthcare recalled 51,144 Airvo 2 and myAirvo 2 humidifiers in the United States. The devices may emit an audible alert for less than 120 seconds after power is disconnected. This could delay user awareness to reconnect power and lead to oxygen desaturation. Patients and healthcare providers should stop using the device and await manufacturer instructions.
When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120 seconds, which may delay user awareness to reconnect power, which could lead to oxygen desaturation, hypoxia. Disinfection kit user manual updated to include checking the audible alert prior to use on a new patient.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Fisher & Paykel Healthcare, Ltd. or your healthcare provider for instructions. Notification method: Letter
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Airvo 2 and myAirvo 2 humidifiers deliver high-flow warmed and humidified respiratory gases. They are used in clinical settings and, in some cases, home care if prescribed.
The device may emit an audible alert for fewer than 120 seconds after losing power, delaying power reconnection and risking patient oxygen desaturation.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics using these devices may experience brief alarm delays during power loss, requiring staff to verify power status promptly.
Refer to the FDA recall page and Fisher & Paykel Healthcare’s official channels for guidance.
No specific timeline is provided for remedies or replacements.
Keep recall notice, model numbers, UID codes, correspondence, and dates of any actions taken.
Models PT101US (UDI-DI 9420012422347) and PT100US (UDI-DI 9420012422248) were recalled. The Disinfection Kit User Manual revision UI-185043723 rev P is part of the recall. Quantity: 51,144 units. Distribution: US nationwide. Recall date: 2025-09-18. Status: ACTIVE. Manufacturer: Fisher & Paykel Healthcare Ltd.
No injuries or incidents have been reported.
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