Hamilton Medical AG: Medical Device Recall in 2022 - (Recall #: Z-1385-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

HAMILTON-H900 Humidifier, Models: 950001, 950004

Product Classification:

Class III

Date Initiated: January 5, 2021

Date Posted: July 20, 2022

Recall Number: Z-1385-2022

Event ID: 90460

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.

Status: Completed

Product Quantity: 203

Code Information:

UDI:07630002801546. All devices with software version 1.10c

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated