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# Hamilton Medical Removes Breathing Circuit Set
- URL: https://www.fdaweb.com/hamilton-medical-removes-breathing-circuit-set/
- Published: 2026-08-11T12:00:00.000Z
- Updated: 2026-09-14T13:44:53.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161607

An updated Class 1 recall notice says Hamilton Medical is recommending that certain coaxial breathing circuit sets used with HAMILTON-C1, HAMILTON T-1, and HAMILTON-MR1 ventilators be removed from where they are used or sold.

Hamilton Medical says that certain lots of coaxial breathing circuit sets preassembled with an expiratory valve set do not perform as intended. “In some cases, the expiratory valve membrane adhered to the sealing ring on the body of the expiratory valve, impairing valve opening and expiratory gas flow,” the [notice says](https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/breathing-circuit-set-recall-hamilton-medical-removes-breathing-circuit-set?utm%5Fmedium=email&utm%5Fsource=govdelivery). “The issue is not detected during the pre-operative test of the ventilator unless a test lung is actively ventilated. If the expiratory valve membrane is adhered to the sealing ring, the malfunction appears within the first breaths after ventilation is initiated.”

When the expiratory gas flow is obstructed, the end-expiratory pressure is too high, or the end-expiratory flow is too low, the notice says. This will set off the device’s “Exhalation Obstructed” alarm. “An obstruction of expiratory flow results in inadequate ventilation and impaired gas exchange," the notice says. ”Acute respiratory compromise due to impaired exhalation may result in inadequate ventilation and oxygen desaturation (hypoxemia).”

As of last month, the company has reported four serious injuries and no deaths associated with the issue.