Airvo 2 (Fisher & Paykel) – Power Disconnection Risk (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
Brand
Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand
Lot Codes / Batch Numbers
REF/UDI-DI: PT101US/9420012422347, PT100US/9420012422248. Disinfection Kit User Manual all revisions before UI-185043723 rev P
Products Sold
REF/UDI-DI: PT101US/9420012422347; PT100US/9420012422248. Disinfection Kit User Manual all revisions before UI-185043723 rev P
Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand is recalling Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI- due to When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound a. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 9/18/2025, correction notices were communicated via email and phone call. Customers were asked to do the following: 1) Prior to use on a new patient, follow the instructions of the updated Disinfection Kit User Manual. 2) If you have distributed affected devices, notify your customers and include a copy of this notice. 3) Please report all device-related incidents to the firm, distributor or local representative. 3) Complete and return the response form via email to FieldActionUSCA@fphcare.com The Disinfection Kit User Manual updated to include: 7a: Perform Power-Out Alarm test Ensure steps 1-6 have been carried out, so that the alarm circuit is charged . Unplug the unit from the mains/utility power socket . Check that the audible alarm sounds for at least 120 seconds . The unit is now ready for storage . User Manuals can be downloaded from the following links: Airvo 2: https://resources.fphcare.com/content/airvo-manual-uk-us-and-az-ui-185045495-h-15thmarch22.pdf myAirvo 2: https://resources.fphcare.com/content/myairvo2-user-manual-ui-185045490.pdf Disinfection Kit: https://resources.fphcare.com/content/airvo-2-disinfection-manual-user-instructions-ui-185043723.pdf Please note, as per the "Technical Information" section of the Product Technical Manual and the User Manual, the expected service life is 5 years. If you have any questions, please contact the firm's Customer Care via email at FieldActionUSCA@fphcare.com or directly at +1 (800) 446 3908 ext 5003 or +1 (949) 453 4000 ext 5003.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026