FDA Device recall Z-1385-2022
HAMILTON-H900 Humidifier, Models: 950001, 950004
- FDA Device
- Class III
- completed
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class III recall of HAMILTON-H900 Humidifier, Models: 950001, 950004 by Hamilton Medical Ag, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1385-2022 |
| Classification | Class III |
| Status | completed |
| Initiated | 2021-01-05 |
| Published | 2022-07-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Hamilton Medical Ag |
| Distribution | CA, FL, NV, PA, TX, WI |
Product
HAMILTON-H900 Humidifier, Models: 950001, 950004
Reason
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.
Identifiers
| code_info | UDI:07630002801546. All devices with software version 1.10c |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1385-2022%22
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