# FDA recall Z-1823-2024

> **Fisher & Paykel Healthcare, Ltd.** · Class II · device recall initiated 2024-04-02.

## Product

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

## Reason for recall

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.

## Distribution

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

## Key facts

- **Recall number:** Z-1823-2024
- **Recalling firm:** Fisher & Paykel Healthcare, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-02
- **Report date:** 2024-05-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Auckland, N/A, New Zealand

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1823-2024

## Citation

> AI Analytics. FDA recall Z-1823-2024. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/Z-1823-2024. Source: US FDA. Licensed CC0.

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