FDA recall, , High risk
Hamilton Medical Coaxial Breathing Circuit Sets
The coaxial breathing circuit may have expiratory valve membranes sticking, causing an exhalation obstructed alarm and inadequate ventilation.
Summary by Recall Canary from the FDA notice
What happened
Hamilton Medical AG is recalling its coaxial breathing circuit sets, including REF 260127, 260128, 260167, and 260168, used with HAMILTON-C1, HAMILTON-T1, and HAMILTON-MR1 ventilators. The recall was initiated on May 29, 2026, and added to the FDA's Enforcement Report on June 30, 2026.
The circuit may have expiratory valve membranes sticking to the valve body, which is not detectable during pre-operative tests and can result in an "exhalation obstructed " alarm, which may result in inadequate ventilation and oxygen desaturation.
The products were distributed nationwide across the United States, including states such as Alaska, California, Florida, Texas, and others. The company advised testing lung action prior to use.
What to do
If a code on your device is listed below:
- Advising: Prior to use, test lung action.
- If alarm occurs, expiratory valve set removal to overcome membrane adhesion or replacement.
Is your set affected?
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with Hamilton-C1, Hamilton-T1 and Hamilton-MR1 ventilators.
- UDI-DI
- 07630002802956
- 17630002802953
- 07630002802963
- 17630002802960
- 07630002802970
- 17630002802977
- 07630002802987
- 17630002802984
- Lot code
- 200379
- 205050
Recall details
- Company began the recall
- Sold in
US Nationwide distribution including in the states of Kansas, Washington, Vermont, Texas, Wisconsin, Arkansas, Ohio, Pennsylvania, California, Colorado, Idaho, Arizona, Maine, Missouri, Michigan, Illinois, Oregon, Virginia, Florida, New Jersey, South Dakota, New York, New Mexico, Tennessee, Connecticut, Nebraska, Oklahoma, Alabama, Georgia, Kentucky, New Hampshire, Wyoming, North Dakota, Indiana, Utah, West Virginia, Delaware, Iowa, PR, Minnesota, Louisiana, Alaska, Hawaii.
- Company
- Hamilton Medical AGDomat/Ems, Switzerland
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99028
- Recall number
- Z-2463-2026
- Quantity recalled
- 27,270 pcs
All recalls from Hamilton Medical AG
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
