Recall Z-2463-2026— Hamilton Medical AG
Class I · Ongoing
Class I FDA medical device recall by Hamilton Medical AG, initiated 2026-05-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.. Reason: Ventilator 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.
- Recalling firm
- Hamilton Medical AG
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2026-05-29
- Firm location
- Domat/Ems, N/A, Switzerland
Product description
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
Reason for recall
Ventilator 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.