An expiratory valve membrane that may stick, leaving breath unable to escape — 56 device records mention injury, four mention death (27,270 breathing circuits)
In coaxial breathing circuit sets used with HAMILTON-C1, T1 and MR1 ventilators, membranes in the expiratory valve set may stick to the valve body. The record states the fault is not detectable during the pre-operative test. Classified Class I for possible inadequate ventilation and oxygen desaturation; 27,270 pieces reached 43 states and Puerto Rico.
Recall overview (primary data)
- ClassificationClass I (most serious)
- Product typeMedical Device
- Recalling firmHamilton Medical AG
- ReasonVentilator 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
- DistributionUS 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...
- Recall initiated2026-05-29
Key points
- The product is the coaxial breathing circuit set (REF 260127, 260128, 260167, 260168) for HAMILTON-C1, T1 and MR1 ventilators — 27,270 pieces.
- Membranes in the expiratory valve set may stick to the valve body, producing an exhalation obstructed alarm and possible inadequate ventilation and oxygen desaturation.
- The record states plainly that the fault is not detectable during the pre-operative test.
- The firm advises testing lung action before use and, if the alarm occurs, removing the expiratory valve set to overcome adhesion or replacing it.
- Of the 1,408 recall records this site holds as of 2026-08-28, this is the only one whose reason says the fault cannot be detected.
- Among the 779 device records this site holds as of 2026-09-01, 56 name injury as a possible consequence and four name death.
1What happens on the exhaling side of a ventilator circuit
A ventilator is not merely a device that pushes air in. The path by which that air leaves the lungs matters just as much, and at that exit sits the expiratory valve. When the membrane used there sticks to the valve body, the route for exhaled air closes. The device detects this and raises an exhalation obstructed alarm — but an alarm sounding also means ventilation has already become inadequate at that point. From the side of the patient it can appear as a fall in oxygen saturation.
2A fault that slips past the pre-use check
The heaviest sentence in this record is the one saying the fault is not detectable during the pre-operative test. Much of the safety of medical devices rests on going through a check before use. If that check does not find it, then the procedure can be followed correctly and the hazard still remains.
The firm advises testing lung action and, should the alarm occur, removing or replacing the expiratory valve set — advice that is less about detecting the fault in advance than about knowing the response before it happens.
3Only 1 of 1,408 records says it cannot be detected
Of the 1,408 FDA recall records this site holds as of 2026-08-28, exactly one includes wording in its reason to the effect that the fault cannot be detected — this one. Most of the 779 device recalls cite breakage, leaks, mislabeling or loss of sterility: faults that a check will reveal. A record in which the firm itself writes that checking will not reveal it is different in kind.
How often the membrane sticks, and whether harm actually occurred, are not part of this record.
4What device reasons say about consequence
Of the FDA recall records this site holds as of 2026-09-01, 779 are devices. Among their reasons, 56 name injury as a possible consequence and four name death.
Most records describe the fault and stop there, without saying what follows from it. A record that reaches the consequence means the firm set out the harm it envisaged. A case like this one, where the path to a patient unable to exhale can be read, is uncommon among device recalls.
Why it matters
A fault a pre-use check can find and one it cannot mean entirely different things on the floor. The first is handled by enforcing the procedure; the second can only be met by distributing a response in advance. That the firm advises what to do when the alarm sounds, rather than how to detect the fault, reflects exactly that.
FAQ
What is the expiratory valve?
What does not detectable during the pre-use test mean?
Did harm actually occur?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: Z-2463-2026