RegWardenFDA facility compliance records
Company

HAMILTON MEDICAL, INC.

10 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2012: 1 recalls; 2013: 1 recalls; 2014: 1 recalls; 2015: 2 recalls; 2016: 2 recalls; 2017: 1 recalls; 2023: 2 recalls1’121’131’142’152’161’17’18’19’20’21’222’23’24’25’26
  • Recalls (10)

Registered facilities (1)

Recalls & enforcement

  • Class IOngoing2023-07-26
    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 of ventilation.
  • Class IOngoing2023-06-15
    Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
  • Class IIOngoing2017-06-20
    Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
  • Class IITerminated2016-09-26
    Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation.
  • Class IITerminated2016-03-09
    After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected.
  • Class IITerminated2015-06-01
    An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the inaccurate flow measurement and decrease the amount of ventilation d…
  • Class IITerminated2015-03-24
    Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device.
  • Class ITerminated2014-04-22
    Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the activation of a suctioning maneuver by the operator; this situation can occur regardless of the selected patient group (neonatal, pediatric and adult).
  • Class IITerminated2013-09-26
    Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded.
  • Class ITerminated2012-12-19
    Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a Hamilton T1 ventilator with software versions 1.1.2 and lower must be calculated using a larger margin t…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “HAMILTON MEDICAL, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-2937708-hamilton-medical-inc/

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