Reported May 22, 2024 · Ongoing

Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US

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 · N/A

Is this the product you have?

  • Airvo 2 Humidifier
  • REF
    • PT101US
    • and myAirvo 2 Humidifier
  • REFPT100US
Lot codes and dates
  • REF/UDI-DI
    • PT100US/09420012422248
    • PT101US 09420012422347
  • Serial Number Range120521XXXXXX - 170813XXXXXX
  • NoteX digits are variable and do not affect the identification of the affected range. Devices manufactured before 14 August 2017
Amount recalled
7,147

Where it was sold

Why it was recalled

Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, intermittent or inaudible alarm sound levels. In the absence of an audible alarm, if there is an interruption to therapy, a patient may experience oxygen desaturation.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.