Airvo 2 Humidifier — Class II medical device recall Z-1823-2024
Ongoing recall by Fisher & Paykel Healthcare, Ltd., reported 2024-05-22, distributed nationwide. Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2
| Recall number | Z-1823-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fisher & Paykel Healthcare, Ltd., Auckland, N/A, New Zealand |
| Recall initiated | 2024-04-02 |
| Classified | 2024-05-15 |
| Reported by FDA | 2024-05-22 |
| Distributed | Nationwide (US) |
| Quantity | 7,147 |
| UPC / GTIN / UDI-DI | 09420012422248, 09420012422347 |
| Model numbers | PT100US, PT101US |
Product
Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1823-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.