Z-1823-2024Class II

Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US

Name: Z-1823-2024 Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
Creator: Fisher & Paykel Healthcare, Ltd.
Published: 2024-04-02
License: https://open.fda.gov/license/

Fisher & Paykel Healthcare, Inc. / initiated 2024-04-02 / Open, Classified / root cause: manufacturing process

FDA source

Fisher & Paykel Healthcare, Ltd. began a recall of Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US on 2024-04-02. FDA classified it as Class II and gives the reason as "Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, intermittent or inaudible alarm sound levels...". 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-1823-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-02
Posted: 2024-05-15
Recalling firm: Fisher & Paykel Healthcare, Inc.
Product: Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
Product code: BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Reason for recall: Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, intermittent or inaudible alarm sound levels. In the absence of an audible alarm, if there is an interruption to therapy, a patient may experience oxygen desaturation.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 4/2/24, recall notices were sent to biomedical and respiratory department customers informing them to do the following: 1) Quarantine affected devices and work with firm to arrange collection and replacement. 2) Should a patient need to continue to use the device, the patient is instructed to contact their physician. Distributors are asked to facilitate device collection and replacement for their customers: a) If affected product has been further distributed create a list of affected customers for tracking purposes. b) Use the firm provided templates to create recall letters and response forms. Send the recall notice and response form to your customers to whom your firm has distributed affected devices. c) This recall notice should be shared with anyone who needs to be aware both within your organization and forwarded to any organization/ where potentially affected devices have been transferred. 3) Complete and return the response form via email at [email protected] Firm is removing and replacing affected devices. If you have any questions, please contact firm 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: 7,147
Distribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
Product codes and lots: REF/UDI-DI: PT100US/09420012422248, PT101US 09420012422347. Serial Number Range: 120521XXXXXX - 170813XXXXXX Note: X digits are variable and do not affect the identification of the affected range. Devices manufactured before 14 August 2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1823-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1823-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-15

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)