Recall Z-0158-2026— Fisher & Paykel Healthcare, Ltd.
Class II · Ongoing
Class II FDA medical device recall by Fisher & Paykel Healthcare, Ltd., initiated 2025-09-18. It names one FDA 510(k) clearance: K131895. Product: Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723. Reason: 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..
- Recalling firm
- Fisher & Paykel Healthcare, Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-18
- Firm location
- Auckland, New Zealand
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.