CLASS III Device recall · Reported 20 Jul 2022 · FDA Enforcement Report

Hamilton-H900 Humidifier recalled by Hamilton Medical AG

Hamilton Medical is recalling Hamilton-H900 Humidifier, distributed in California, Florida, Nevada, Pennsylvania, Texas, Wisconsin. The recall was initiated on 5 Jan 2021 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesUDI:07630002801546. All devices with software version 1.10c

Quantity recalled203

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1385-2022
FDA event ID: 90460
Recalling firm: Hamilton Medical, Bonaduz
Classification: Class III
Status: Completed
Recall initiated: 5 Jan 2021
FDA classified: 14 Jul 2022
Reported: 20 Jul 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

5 Jan 2021	Recall initiated by company
14 Jul 2022	Classified by FDA	+555 days
20 Jul 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

HAMILTON-H900 Humidifier, Models: 950001, 950004

Where it was distributed

US: WI, FL, CA, NV, PA, TX, PA

California Florida Nevada Pennsylvania Texas Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI:07630002801546. All devices with software version 1.10c

Where was it sold?

US: WI, FL, CA, NV, PA, TX, PA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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