Hamilton Medical recalls
11 official recalls and safety alerts involving Hamilton Medical since 2022-07, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Hamilton Medical or the relevant agency.
- 2026-07-08
USHamilton Medical AG recalls IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.
FDA · DeviceHamilton Medical AGWorldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA,…Official notice →- US
Hamilton Medical AG recalls Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may…
FDA · DeviceHamilton Medical AGUS Nationwide distribution including in the states of KS, WA, VT, TX, WI, AR,…Official notice → - 2025-08-27
- US
Hamilton Medical AG recalls Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive…
A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use of the device…
- 2025-08-06
- US
Hamilton Medical AG recalls Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and…
Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete…
FDA · DeviceHamilton Medical AGUS Nationwide distribution in the states of NH, NY, CT, PA, IL, ME, CO, NC,…Official notice → - 2024-06-26
- US
Hamilton Medical AG recalls Ventilator HAMILTON-C6, PN: 160021
Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube…
FDA · DeviceHamilton Medical AGUS Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR,…Official notice → - 2023-09-27
- US
Hamilton Medical, Inc. recalls Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption…
FDA · DeviceHamilton Medical, Inc.Distribution US nationwide, including Puerto Rico. OUS: Not providedOfficial notice → - 2023-08-02
- US
Hamilton Medical, Inc. recalls HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally…
Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
FDA · DeviceHamilton Medical, Inc.U.S.: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware…Official notice → - 2023-05-03
- US
Hamilton Medical AG recalls HAMILTON-C6, REF: 160021
Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs are not monitored, if the following coincide 1) A mode change to an…
FDA · DeviceHamilton Medical AGUS Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA,…Official notice → - 2022-11-30
- US
Hamilton Medical AG recalls Hamilton-C6
Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for approximately 2-3 seconds, but it brightens up again when the backlight switches on again.
FDA · DeviceHamilton Medical AGU.S. Nationwide distribution including in the states of CA, FL, GA, ID, IN,…Official notice → - 2022-08-31
- US
Hamilton Medical AG recalls HAMILTON-C6 Intensive Care Ventilator, REF: 160021
Ventilator status indicator board can become loose, which could lead to water ingress (disinfectants) that may lead to technical fault alarms. Multiple technical faults in a short time may force ventilators into Safety…
- 2022-07-20
- US
Hamilton Medical AG recalls HAMILTON-H900 Humidifier, Models: 950001, 950004
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…