Quick Facts at a Glance
- Recall Date
- September 18, 2025
- Hazard Level
- HIGH
- Brand
- Fisher & Paykel Healthcare
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Fisher & Paykel Healthcare
- Product type
- Humidifier for respiratory therapy
- Model numbers
- PT101US, PT100US, 9420012422347, 9420012422248
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 18, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Fisher & Paykel Healthcare, Ltd. or your healthcare provider for instructions. Notification method: Letter
About This Product
Airvo 2 and myAirvo 2 humidifiers deliver high-flow warmed and humidified respiratory gases. They are used in clinical settings and, in some cases, home care if prescribed.
Why This Is Dangerous
The device may emit an audible alert for fewer than 120 seconds after losing power, delaying power reconnection and risking patient oxygen desaturation.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics using these devices may experience brief alarm delays during power loss, requiring staff to verify power status promptly.
Practical Guidance
How to identify if yours is affected
- Confirm device model PT101US or PT100US.
- Review Disinfection Kit Manual revision UI-185043723 Rev P.
Where to find product info
Refer to the FDA recall page and Fisher & Paykel Healthcare’s official channels for guidance.
What timeline to expect
No specific timeline is provided for remedies or replacements.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- File a complaint with the FDA or relevant health agency if the company is unresponsive.
How to prevent similar issues
- Regularly check recall databases for medical devices you own.
- Verify model numbers before use.
- Ensure power supplies are functional and within facility backup procedures.
Documentation advice
Keep recall notice, model numbers, UID codes, correspondence, and dates of any actions taken.
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Product Details
Models PT101US (UDI-DI 9420012422347) and PT100US (UDI-DI 9420012422248) were recalled. The Disinfection Kit User Manual revision UI-185043723 rev P is part of the recall. Quantity: 51,144 units. Distribution: US nationwide. Recall date: 2025-09-18. Status: ACTIVE. Manufacturer: Fisher & Paykel Healthcare Ltd.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Audible alert under 120 seconds after power loss
- PT101US and PT100US models
- Disinfection Kit UI-185043723 rev P included
- US nationwide distribution
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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