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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.

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High RiskFDA Device
Medical Devices/Home Healthcare

Fisher & Paykel Healthcare, Ltd.: Airvo 2 and myAirvo 2 Humidifiers Recalled for Alarm Failure

Agency Publication Date: May 15, 2024
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Summary

Approximately 7,147 Airvo 2 and myAirvo 2 Humidifier devices, used to deliver high-flow respiratory therapy, have been recalled because their internal speakers may fail. These devices, manufactured before August 14, 2017, may have alarm sound levels that are distorted, intermittent, or completely inaudible. If the alarm does not sound during a therapy interruption, patients may not be alerted to a loss of respiratory support, which can lead to serious health consequences. Consumers should contact the manufacturer or their healthcare provider to determine if their specific device is affected and to receive further instructions.

Risk

The speaker configuration can fail, causing critical safety alarms to be silent or unintelligible. If the device stops delivering oxygen or therapy and the alarm fails to sound, the patient may experience oxygen desaturation (a dangerous drop in blood oxygen levels).

What You Should Do

  1. Identify if your device is affected by checking the model and serial number on the back or bottom of the unit. The recall includes Airvo 2 Humidifier (REF: PT101US) and myAirvo 2 Humidifier (REF: PT100US).
  2. Check the serial number on your device; affected units fall within the range 120521XXXXXX to 170813XXXXXX (where X digits vary). Only devices manufactured before August 14, 2017, are included in this recall.
  3. Immediately contact your healthcare provider or Fisher & Paykel Healthcare to discuss the safety of your device and to obtain guidance on necessary repairs or replacements.
  4. If you are currently using one of these devices, ensure you or a caregiver are closely monitoring the patient and the device's visual display until you have contacted the manufacturer.
  5. For additional questions or to report issues, contact Fisher & Paykel Healthcare directly or call the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Airvo 2 Humidifier
Model / REF:
PT101US
UPC Codes:
09420012422347
Lot Numbers:
Serial Number Range: 120521XXXXXX - 170813XXXXXX
Date Ranges: Manufactured before 14 August 2017
Product: myAirvo 2 Humidifier
Model / REF:
PT100US
UPC Codes:
09420012422248
Lot Numbers:
Serial Number Range: 120521XXXXXX - 170813XXXXXX
Date Ranges: Manufactured before 14 August 2017

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94398
Status: Active
Manufacturer: Fisher & Paykel Healthcare, Ltd.
Sold By: Medical equipment distributors; Healthcare providers
Manufactured In: New Zealand
Units Affected: 7,147
Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming

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.