# FDA recall Z-3262-2024

> **Fisher & Paykel Healthcare, Ltd.** · Class II · device recall initiated 2024-08-07.

## Product

PT301US Airvo 3 Respiratory Support Device  with software version 1.2.0 and/or 1.5.1    The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.

## Reason for recall

Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only.  If this happens, a patient my experience oxygen desaturation that could lead to hypoxia.

## Distribution

U.S.: AZ, CA, CO, CT, DC, FL, GA, IA, IL, KY, MA, MD, MI, MN, MO, MT, ND, NH, NJ, NV, NY, OH,  OR, PA, SD, TX, UT, VA and WA.  O.U.S.: Not provided

## Key facts

- **Recall number:** Z-3262-2024
- **Recalling firm:** Fisher & Paykel Healthcare, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-07
- **Report date:** 2024-10-02

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3262-2024

## Citation

> AI Analytics. FDA recall Z-3262-2024. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-3262-2024. Source: US FDA. Licensed CC0.

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