Fisher & Paykel Healthcare, Ltd.: Medical Device Recall in 2024 - (Recall #: Z-1823-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 2, 2024

Date Posted: May 22, 2024

Recall Number: Z-1823-2024

Event ID: 94398

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.

Status: Ongoing

Product Quantity: 7,147

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated