Fisher & Paykel Healthcare recalled 51,144 humidifier devices on September 18, 2025. The humidifiers may fail to alert users when disconnected from power, risking oxygen desaturation and hypoxia. Patients and healthcare providers should stop using the device immediately and follow recall 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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The recalled products include Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US. These devices were distributed nationwide in the U.S. The disinfection kit user manual, REF: UI-185043723, has been updated to address the issue.
When disconnected from power, the humidifier may sound an alert for less than 120 seconds, delaying user awareness. This malfunction could lead to serious health risks, including oxygen desaturation and hypoxia.
No specific incidents or injuries have been reported in connection with this recall. The potential risk is significant due to the nature of the device.
Stop using the humidifier immediately. Contact Fisher & Paykel Healthcare for further instructions and follow the recall guidelines provided in the notification letter.
For more information, contact Fisher & Paykel Healthcare at their customer service number or visit their website. Notification letters have been sent to affected users.
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