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Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used… recallZ-0158-2026 · Fisher & Paykel Healthcare, Ltd. · initiated Sep 18, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Fisher & Paykel Healthcare, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On 9/18/2025, correction notices were communicated via email and phone call. Customers were asked to do the following: 1) Prior to use on a new patient, follow the instructions of the updated Disinfection Kit User Manual. 2) If you have distributed affected devices, notify your customers and include a copy of this notice. 3) Please report all device-related incidents to the firm, distributor or local representative. 3) Complete and return the response form via email to [email protected] The Disinfection Kit User Manual updated to include: 7a: Perform Power-Out Alarm test Ensure steps 1-6 have been carried out, so that the alarm circuit is charged . Unplug the unit from the mains/utility power socket . Check that the audible alarm sounds for at least 120 seconds . The unit is now ready for storage . User Manuals can be downloaded from the following links: Airvo 2: https://resources.fphcare.com/content/airvo-manual-uk-us-and-az-ui-185045495-h-15thmarch22.pdf myAirvo 2: https://resources.fphcare.com/content/myairvo2-user-manual-ui-185045490.pdf Disinfection Kit: https://resources.fphcare.com/content/airvo-2-disinfection-manual-user-instructions-ui-185043723.pdf Please note, as per the "Technical Information" section of the Product Technical Manual and the User Manual, the expected service life is 5 years. If you have any questions, please contact the firm's Customer Care via email at [email protected] or directly at +1 (800) 446 3908 ext 5003 or +1 (949) 453 4000 ext 5003.

Recall details

Recall number
Z-0158-2026
Status
Open, Classified
Initiated by the company
Sep 18, 2025
Posted by the FDA
Oct 15, 2025
Recalling firm
Fisher & Paykel Healthcare, Ltd.
Quantity
51,144
Product code
BTT
FDA submissions
K131895
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.

Product description

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

Code information (models, lots, serial numbers)

REF/UDI-DI: PT101US/9420012422347; PT100US/9420012422248. Disinfection Kit User Manual all revisions before UI-185043723 rev P

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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