# FDA recall Z-0158-2026

> **Fisher & Paykel Healthcare, Ltd.** · Class II · device recall initiated 2025-09-18.

## Product

Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723

## Reason for recall

When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120 seconds, which may delay user awareness to reconnect power, which could lead to oxygen desaturation, hypoxia. Disinfection kit user manual updated to include checking the audible alert prior to use on a new patient.

## Distribution

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

## Key facts

- **Recall number:** Z-0158-2026
- **Recalling firm:** Fisher & Paykel Healthcare, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-18
- **Report date:** 2025-10-22

- **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-0158-2026

## Citation

> AI Analytics. FDA recall Z-0158-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0158-2026. Source: US FDA. Licensed CC0.

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