Use cautionMedical device recall · FDA · Published January 5, 2021
Hamilton H900 Humidifier Recall: Delayed Low Water Alarm Risk
Hamilton Medical recalls H900 humidifiers (models 950001, 950004) with software 1.10c due to delayed low water alarm when chamber is empty, risking undetected water absence during medical ventilation.
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.
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Contact the company
📍Recalling firmHamilton Medical AGVia Crusch 8 · Bonaduz, Switzerland
✎ GovInfoNow plain-language explainer
Hamilton Medical is recalling H900 humidifiers with specific model numbers and software version 1.10c. The recall is because these devices may delay the low water alarm when the chamber is empty, which could lead to medical staff not realizing there's no water during critical ventilation procedures. Read more at govinfonow.com/recall/63469-hamilton-h900-humidifier-recall-delayed-low-water-alarm-risk.
“Hamilton H900 Humidifier Recall: Delayed Low Water Alarm Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63469-hamilton-h900-humidifier-recall-delayed-low-water-alarm-risk. Based on FDA recall #Z-1385-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1385-2022%22&limit=1).
The FDA announced on Jan. 5, 2021, that Hamilton Medical AG is recalling HAMILTON-H900 Humidifiers, models 950001 and 950004, due to a delayed low water level alarm when the chamber is empty. This defect may prevent medical staff from knowing there is no water in the device. The agency issued recall number Z-1385-2022.
How to tell if you have it
Brand: Hamilton Medical
Product: HAMILTON-H900 Humidifier
Models: 950001, 950004
Software version: 1.10c
UDI: 07630002801546
The hazard
When starting the humidifier with an empty chamber, the low water level alarm will be delayed, leaving medical staff unaware that there is no water in the chamber. The device is intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation.
Context
GovInfoNow's records show Hamilton Medical AG has issued 11 other recalls since March 9, 2018. Recent brand recalls include a May 29, 2026 breathing circuit set risk for exhalation obstruction and a May 22, 2026 IntelliCuff recall for cuff system leakage errors. Other recent recalls of similar products include the Laborie Solar GI System recall (May 21, 2026), the Fresenius Medical Care 2008T BlueStar Hemodialysis Machine recall (June 30, 2026), and the Baxter Blue Ventilator Adapter Module recall (Feb. 18, 2026).
How to tell if you have this one
Check for model numbers 950001 or 950004 on the device. Devices with software version 1.10c are affected. The recall applies to all units sold with these specifications.
Brand
Hamilton Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your humidifier; affected units have version 1.10c.
Ensure Water Level
Always fill the chamber with water before starting the humidifier to prevent delayed alarms.
Where it went and when
Where it was distributed
Distributed in 6 states.
Listed by the agency
Not listed
FDA distribution: “US: WI, FL, CA, NV, PA, TX, PA” States read from FDA’s own wording; “not listed” means the notice does not name it.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1385-2022 (January 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1385-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.