Reported Oct 22, 2025 · Ongoing
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
Fisher & Paykel Healthcare, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fisher & Paykel Healthcare, Ltd. · 15 Maurice Paykel Place · Auckland · N/A
Is this the product you have?
- Airvo 2
- REF
PT101USand myAirvo 2
- REFPT100US, used with Disinfection Kit User Manual
- REFUI-185043723
- Lot codes and dates
2 of 2 products · 2 lot codes
Recalled lot codes, grouped by product number REF UDI-DI PT101US9420012422347
PT100US9420012422248. Disinfection Kit User Manual all revisions before UI-185043723 rev P
- Amount recalled
- 51,144
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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