Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723

FDA device recall Z-0158-2026 · posted 2025-10-15 · Open, Classified

Recall details

Recalling firm

Fisher & Paykel Healthcare, Ltd.

Reason for recall

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

BTT

Quantity affected

51,144

Distribution

US Nationwide distribution including in the states of TX, MS, LA, NC, TN, NY, FL, IL, UT, MT, OH, MI, NJ, AR, GA, WI, CA, IN, OK, CO, AL, SC, AZ, MD, WA, MO, PA, MA, NH, KY, KS, VA, CT, MN, ND, NM, NE

Date initiated

2025-09-18

Date posted

2025-10-15

Location

Auckland, East Tamaki, New Zealand

Related 510(k) clearances