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. 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. Initially customers were informed to continue use and perform actions to mitigate risk, but later the updated notice called for affected device removal. On 7/8/2026, updated recall notices were emailed and mailed to healthcare facilities, physicians and end users who were informed of the following: 1) Discontinue use and quarantine affected devices. 2) Do not follow previous instructions for product modification. 3) Inform all affected end users and/or sub-distributors and provide them with this notice. 4) Contact firm if you have affected product in inventory. - Discard any affected product(s) and confirm destruction. Or - Contact Hamilton Medical for a return material authorization number and return label. -Contact your sales representative to acquire replacement product. 5) Complete and return the Facility Reply Form.

• 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.