HAMILTON-H900 Humidifier — Class III medical device recall Z-1385-2022
Completed recall by Hamilton Medical AG, reported 2022-07-20, distributed in CA, FL, NV, PA, TX, WI. When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanic
| Recall number | Z-1385-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hamilton Medical AG, Bonaduz, Switzerland |
| Recall initiated | 2021-01-05 |
| Classified | 2022-07-14 |
| Reported by FDA | 2022-07-20 |
| Distributed | CA, FL, NV, PA, TX, WI |
| Quantity | 203 |
| UPC / GTIN / UDI-DI | 07630002801546 |
| Model numbers | 950001, 950004 |
Product
HAMILTON-H900 Humidifier, Models: 950001, 950004
Reason for recall
When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber.
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-1385-2022. 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.