Manufacturer

Hamilton Medical AG

14 recalls in our database name Hamilton Medical AG as the manufacturing or recalling firm.

What the numbers show

Total: 14
Critical: 1
Severe: 5
Most recent: 2026-07-08

Of the 14 recalls from Hamilton Medical AG we have scored against our rubric, 1 (7%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (36%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–14 of 14

SevereFDA (Devices)·Z-2463-2026·2026-07-08
Ventilator breathing circuit sets may obstruct exhalation valve
Hamilton Medical AG is recalling coaxial breathing circuit sets used with three ventilator models because membranes may stick to the expiratory valve body, preventing proper gas exhalation and potentially causing inadequate ventilation.
Product
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2625-2026·2026-07-08
IntelliCuff Portable Automatic Cuff Pressure Controller Recall
Hamilton Medical AG is recalling the IntelliCuff portable automatic cuff pressure controller due to a reported "Cuff System Leakage" error that may cause the motor to pump continuously and fail to maintain user-set cuff pressure.
Product
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2328-2025·2025-08-27
Hamilton C6 ventilators recalled over circuit board defect interrupting ventilation
Hamilton C6 ventilators are recalled over a mechanical defect on a printed circuit board that may cause the device to fail at startup or interrupt ventilation during use. 1,040 systems are affected.
Product
Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2167-2025·2025-08-06
Hamilton coaxial breathing circuits may have a crack in blue tubing
Coaxial breathing circuit sets for HAMILTON-C1, T1 and MR1 ventilators are being recalled because the blue tubing that delivers fresh gas may be cracked, which can cause rebreathing of exhaled gases. 2,560 units affected.
Product
Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2020-2024·2024-06-26
Ventilator HAMILTON-C6 may fail to restart, risking oxygen deprivation
Hamilton Medical AG is recalling the HAMILTON-C6 ventilator due to a sensor failure that may prevent re-initiation after reconnection, potentially causing hypoxia.
Product
Ventilator HAMILTON-C6, PN: 160021
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1429-2023·2023-05-03
Hamilton HAMILTON-C6 Ventilator Software Error Disables Patient Input Monitoring
The HAMILTON-C6 ventilator (103 units) has a software error that disables patient input monitoring when switching to adaptive ventilation modes with a connected controller or humidifier. The device will alarm but cannot respond to patient inputs.
Product
HAMILTON-C6, REF: 160021
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0267-2023·2022-11-30
Ventilator Screen Backlight Malfunction Causes Temporary Display Loss
Hamilton-C6 ventilators are subject to a backlight malfunction causing the display screen to go black for 2-3 seconds. The FDA has classified this Class II recall as affecting 443 U.S. systems distributed nationwide.
Product
Hamilton-C6
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1525-2022·2022-08-31
Intensive care ventilator status board may loosen, causing water damage and malfunction
Hamilton's HAMILTON-C6 intensive care ventilator status indicator board may become loose, allowing water or disinfectants to enter the device and cause technical faults that could force the ventilator into unsafe modes where patients breathe unassisted room air.
Product
HAMILTON-C6 Intensive Care Ventilator, REF: 160021
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1385-2022·2022-07-20
HAMILTON-H900 Humidifier Recall Due to Delayed Low-Water Alarm
Hamilton Medical's HAMILTON-H900 humidifier (models 950001, 950004) is recalled due to delayed low-water level alarms that may prevent medical staff from detecting an empty chamber during mechanical ventilation use.
Product
HAMILTON-H900 Humidifier, Models: 950001, 950004
Category
Medical Device
Distribution
6 states
SevereFDA (Devices)·Z-1874-2019·2019-07-17
Hamilton Medical Recalls HAMILTON-G5 Ventilators Due to Ambient State Risk
Hamilton Medical is recalling 4,338 HAMILTON-G5 ventilators with software versions 2.60 or lower because they may enter an ambient state, requiring immediate alternative ventilation.
Product
HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutio
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2795-2018·2018-08-22
Hamilton-C1 Ventilator Recall Due to Control Board Component Defect
Hamilton Medical AG is recalling 16 Hamilton-C1 ventilators because a defective control board component may cause the device to shut down and trigger alarms.
Product
Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics. The device is used in the in the intensive care ward, in the recovery room, and during transfer of ventilated patients
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-2796-2018·2018-08-22
Hamilton-C3 Ventilator Recalled Due to Control Board Component Defect
Hamilton Medical AG is recalling two Hamilton-C3 ventilators because an out-of-specification control board component may cause the device to shut down and trigger alarms.
Product
Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants and neonates depending on its configuration. The device is used in the intensive care ward, intermediate care ward,
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1372-2018·2018-04-18
Hamilton-C3 Ventilator Battery Fuel Gauge Recall
Hamilton Medical AG is recalling 739 Hamilton-C3 Ventilator Units worldwide because the battery fuel gauge may inaccurately indicate a higher charge than available.
Product
Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-1371-2018·2018-04-18
Hamilton-C2 Ventilator Units Recalled Due to Battery Fuel Gauge Inaccuracy
Hamilton Medical AG is recalling 739 Hamilton-C2 Ventilator Units worldwide because the battery fuel gauge may inaccurately indicate a higher charge than available.
Product
Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
Category
Medical Device
Distribution
29 states