Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Home Healthcare

Fisher & Paykel Airvo 2 Humidifiers Recalled for Power Alert Defect

Agency Publication Date: October 15, 2025
Share:
Sign in to monitor this recall

Summary

Fisher & Paykel Healthcare, Ltd. has recalled approximately 51,144 Airvo 2 and myAirvo 2 humidifier devices used to deliver high-flow humidified air to patients. The devices may sound an audible alert for less than 120 seconds if they are unintentionally disconnected from power, which is shorter than intended. This shorter alert could delay a caregiver's awareness that the device has lost power, which could lead to a patient suffering from low blood oxygen levels (hypoxia). Owners should contact the manufacturer or their distributor to receive an updated user manual that includes critical instructions for testing the power-loss alarm.

Risk

The power-loss alarm may stop sounding too early, meaning caregivers might not realize a patient's respiratory support has been interrupted. This delay in reconnecting power can lead to dangerous and rapid drops in a patient's oxygen levels.

What You Should Do

  1. This recall involves Fisher & Paykel Airvo 2 and myAirvo 2 humidifier devices used with Disinfection Kit User Manuals (REF UI-185043723) in all revisions prior to Revision P.
  2. Identify if your device is affected by checking for model numbers PT101US or PT100US and Unique Device Identifier codes 9420012422347 or 9420012422248 on the device label. Also, check the reference number and revision letter on the cover of your Disinfection Kit User Manual.
  3. Stop using the recalled device and contact Fisher & Paykel Healthcare or your distributor to arrange for a return, replacement, or correction.
  4. Obtain the updated Disinfection Kit User Manual (Revision P or later), which includes new instructions to check the audible alert before using the device on a new patient.
  5. Contact Fisher & Paykel Healthcare, Ltd. directly for further instructions regarding this manual update.
  6. Call the FDA Consumer Complaint hotline at 1-888-463-6332 with any additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Airvo 2 Humidifier
Model / REF:
PT101US
UDI:
9420012422347

Affected when used with Disinfection Kit User Manual REF: UI-185043723 (all revisions before rev P).

Product: myAirvo 2 Humidifier
Model / REF:
PT100US
UDI:
9420012422248

Affected when used with Disinfection Kit User Manual REF: UI-185043723 (all revisions before rev P).

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97591
Status: Active
Manufacturer: Fisher & Paykel Healthcare, Ltd.
Sold By: Hospitals; Medical clinics; Home healthcare providers
Manufactured In: New Zealand
Units Affected: 51,144
Distributed To: Texas, Mississippi, Louisiana, North Carolina, Tennessee, New York, Florida, Illinois, Utah, Montana, Ohio, Michigan, New Jersey, Arkansas, Georgia, Wisconsin, California, Indiana, Oklahoma, Colorado, Alabama, South Carolina, Arizona, Maryland, Washington, Missouri, Pennsylvania, Massachusetts, New Hampshire, Kentucky, Kansas, Virginia, Connecticut, Minnesota, North Dakota, New Mexico, Nebraska, Iowa, West Virginia, Idaho, Nevada, Oregon, Hawaii, Vermont, Rhode Island, South Dakota, Wyoming, Puerto Rico, Maine

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.