Controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
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2026
FDA Class I Recall of Hamilton Medical Coaxial Breathing Circuits
Recall announced
The FDA classified Hamilton Medical's recall of coaxial breathing circuit sets preassembled with an expiratory valve set as a Class I recall. The circuits are used with HAMILTON-C1, HAMILTON T-1, and HAMILTON-MR1 ventilators, and a valve membrane defect that can block exhaled gas flow was associated with four serious injuries and no deaths. Affected product numbers are 260127, 260128, 260167, and 260168.
Company response
Recall — Hamilton Medical
the FDA classified the action as a Class I recall the next day
Source excerpt
Four Hamilton Medical product numbers are covered: 260127, 260128, 260167, and 260168.
the company had reported four serious injuries and no deaths tied to the issue
the FDA classified the action as a Class I recall the next day