Z-0158-2026Class II

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

Name: Z-0158-2026 Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
Creator: Fisher & Paykel Healthcare, Ltd.
Published: 2025-09-18
License: https://open.fda.gov/license/

Fisher & Paykel Healthcare, Inc. / initiated 2025-09-18 / Open, Classified / root cause: manufacturing process

FDA source

Fisher & Paykel Healthcare, Ltd. began a recall of Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723 on 2025-09-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0158-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-18
Posted: 2025-10-15
Recalling firm: Fisher & Paykel Healthcare, Inc.
Product: Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
Product code: BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 51,144
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 codes and lots: REF/UDI-DI: PT101US/9420012422347; PT100US/9420012422248. Disinfection Kit User Manual all revisions before UI-185043723 rev P

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0158-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0158-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-15

Product code BTT

K131895Class IIAirvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd. / cleared 2013-10-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)