Recall Z-2463-2026

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

FDA-determined cause: Component design/selection

Action taken

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.