Bonaduz, Switzerland
Hamilton Medical AG recalls
12 recalls recorded since 2018, most recently on 29 May 2026. 9 are listed as ongoing. Status and classification are as published by the FDA.
Recalls12
Ongoing (FDA)9
Terminated or completed3
Class I (FDA)6
Ongoing Class I Medical devices
- Recall started
- 29 May 2026
- Reason
- 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 result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal to overcome membrane adhesion or replacement
- Distribution
- US Nationwide distribution including in the states of KS, WA, VT, TX, WI, AR, OH, PA, CA, CO, ID, AZ, ME, MO, MI, IL, OR, VA, FL, NJ, SD, NY, NM, TN, CT, NE, OK, AL, GA, KY, NH, WY, ND, IN, UT, WV, DE, IA, PR, MN, LA, AK, HI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2463-2026
- Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
Ongoing Class II Medical devices
- Recall started
- 22 May 2026
- Reason
- 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.
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IL, KY, MA, MI, ND, NE, NE, NY, OH, PA, PR, SD, TX, VA, WA, WI, WV, WY and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2625-2026
- IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Ongoing Class I Medical devices
- Recall started
- 26 June 2025
- Reason
- 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 rebreathing of exhaled gases, which could lead to acute hypercapnia, respiratory acidosis, and if unrecognized organ dysfunction.
- Distribution
- US Nationwide distribution in the states of NH, NY, CT, PA, IL, ME, CO, NC, NJ, UT, TX, GA, SC, VA, IN, SD, MO, OR, TN, MA, AZ, NM.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2167-2025
- 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.
Ongoing Class I Medical devices
- Recall started
- 3 June 2025
- Reason
- 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 enter ambient state, resulting in an interruption of ventilation.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2328-2025
- 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
Ongoing Class I Medical devices
- Recall started
- 15 May 2024
- Reason
- 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 for open suctioning, 3)Sensor error initiated, sensor fail mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilation is not re-initiated by the ventilator.
- Distribution
- US Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR, TX, SC, CA, PA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2020-2024
- Ventilator HAMILTON-C6, PN: 160021
Ongoing Class II Medical devices
- Recall started
- 14 March 2023
- Reason
- 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 adaptive mode (ASV, APVcmv, APVsimv, INTELLiVENT-ASV, (S)CMV+, SIMV+), and 2) The controller and/or humidifier is connected to the ventilator and is operational.
- Distribution
- US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1429-2023
Ongoing Class II Medical devices
- Recall started
- 22 September 2022
- Reason
- 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.
- Distribution
- U.S. Nationwide distribution including in the states of CA, FL, GA, ID, IN, KS, KY, MA, MI, MO, NV, NM, NY, NC, OH, PA, Puerto Rico, SC, TX, VA, WA, WV, WI, and WY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0267-2023
Ongoing Class I Medical devices
- Recall started
- 27 June 2022
- Reason
- 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 Ventilation (blower runs constantly) or Ambient Sate (inspiratory channel/expiratory valves opened; patient breaths room air unassisted) with Panel connection lost message displayed
- Distribution
- US nationwide distribution including Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1525-2022
- HAMILTON-C6 Intensive Care Ventilator, REF: 160021
Completed Class III Medical devices
- Recall started
- 5 January 2021
- Reason
- 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.
- Distribution
- US: WI, FL, CA, NV, PA, TX, PA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1385-2022
- HAMILTON-H900 Humidifier, Models: 950001, 950004
Terminated Class I Medical devices
- Recall started
- 25 March 2019
- Terminated
- 3 June 2024
- Reason
- New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting the patient breathe room air unassisted. When the ventilator enters the ambient state, alternative ventilation must be provided immediately.
- Distribution
- Worldwide Distribution- US (Nationwide Distribution): MI, WI, OR, MO, TX, NV, PA, SC, HI, MN, ND, NC, AZ, FL, CA, MA, GA, NY, VA, WA, IN, CO, LA, IL, OH, TN, SD, OK, MI, AR, C, AK, WV, NJ, IA, NE, KS, MT, NH, AL, MD, KY, CT, and RI. And (International Distribution): AT, BE, BG, CH, CZ, DE, DK, EE,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1874-2019
- 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. T
Ongoing Class II Medical devices
- Recall started
- 12 March 2018
- Reason
- After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.
- Distribution
- Worldwide Distribution -- USA, including the states of AZ, CA, CO, FL, GA, HI, IL, IN, KY, MA, MI, MN, MO, MT, NC, ND, NE, NV, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, and WA; and, the countries of Algeria, Angola, Argentina, Armenia, Australia, Austria, Austria, Azerbaijan, Bangladesh, Belarus, Belg
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1371-2018, Z-1372-2018
- Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
- Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
Terminated Class II Medical devices
- Recall started
- 9 March 2018
- Terminated
- 18 March 2019
- Reason
- An out of specification component on the control board may cause the ventilator to open the inspiratory channel and the expiratory valve. The ventilator will shut down and an emergency buzzer providing an acoustic alarm and the blinking alarm LED on the device s front side.
- Distribution
- US distribution to CA, CO, IL, LA, MN, NY, OK, VA, WI. Worldwide distribution to China, Germany, India, Indonesia, Israel, Kazakhstan, Korea, Pakistan, Taiwan, Poland, Armenia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2796-2018, Z-2795-2018
- 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
- 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 th
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.