FDA Medical devices recall ·
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US… recall
- Recall number
- Z-0158-2026
- Date
- (initiated September 18, 2025)
- Company / brand
- Fisher & Paykel Healthcare, Ltd.
15 Maurice Paykel Place, Auckland, New Zealand - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 51,144
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
REF/UDI-DI: PT101US/9420012422347; PT100US/9420012422248. Disinfection Kit User Manual all revisions before UI-185043723 rev P
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.
States: Alabama Arkansas Arizona California Colorado Connecticut 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 Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0158-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.