Hamilton Medical AG recalls Breathing circuit set

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

On 5/29/2026, correction notices were emailed to customers who were asked to do the following: 1) Inform all potential users of affected devices within your facility about this issue. 2) Inform all affected end users and/or sub-distributors and provide them with this notice. 3) You may continue to use breathing circuit sets, coaxial with lot numbers mentioned above according to their labelling. Mitigate potential risks by following the actions described in point "Type of Action to mitigate the risk." 4) Contact firm if during ventilation or testing an "exhalation obstructed" alarm occurs, replace the breathing circuit set as needed. - Firm will stay in close contact with the users and provide alternative solutions. - See notice for steps that can be taken to overcome membrane adhesion. 5) Post this notice to ensure all personnel are informed. 6)Complete and return Facility Reply Form via email to complaints@hamiltonmedical.com Customers with questions can contact the firm at the email above. Type of Action to mitigate the risk To mitigate the risk associated with a potentially adhesive expiratory valve membrane, the user is advised to verify unimpeded expiratory gas flow prior to use. After performing the pre-operative test, ventilate a test lung using the following settings: Mode: PCV+ PEEP: 5 mbar Pcontrol: 5 mbar TI: 1 s Rate: 12 b/min If no "exhalation obstructed" alarm is issued, the expiratory valve is safe to use. If the "exhalation obstructed" alarm is triggered, do not use the breathing circuit set, coaxial. The breathing circuit set, coaxial must be discarded and replaced. Please contact Hamilton Medical Inc if this occurs.

• FDA enforcement recordOfficial FDA database entry for Z-2463-2026
• FDA device classification · BZOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5975The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Hamilton Medical AGSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.