Fisher & Paykel Healthcare, Ltd.: Device Recall

Recall #Z-0158-2026 · 09/18/2025

Class II: Risk

Recall Details

Recall Number: Z-0158-2026
Classification: Class II
Product Type: Device
Recalling Firm: Fisher & Paykel Healthcare, Ltd.
Status: Ongoing
Date Initiated: 09/18/2025
Location: Auckland, New Zealand
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 51,144

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.

Product Description

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

Distribution Pattern

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, IA, WV, ID, NV, OR, HI, VT, RI, AL, SD, WY, PR, ME.

Other Recalls by Fisher & Paykel Healthcare, Ltd.

Class II: Risk 08/07/2024

Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happens, a patient my experience oxygen desaturation that could lead to hypoxia.

View all recalls by Fisher & Paykel Healthcare, Ltd. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.