Class 1 Device Recall Hamilton Medical AG

• Date Initiated by Firm: May 29, 2026
• Date Posted: June 30, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2463-2026
• Recall Event ID: 99028
• Product Classification: Set, tubing and support, ventilator (w harness) - Product Code BZO
• Product: Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
• Code Information: REF/UDI-DI: 260127/07630002802956, 17630002802953; 260128/07630002802963, 17630002802960; 260167/07630002802970, 17630002802977; 260168/07630002802987, 17630002802984. Lot numbers between 200379 and 205050 (including both.)
• FEI Number: 3014766741
• Recalling Firm/ Manufacturer: Hamilton Medical AG; Parc Industrial Vial 10; Domat/Ems Switzerland
• For Additional Information Contact: Bret Everett; 800-426-6331 Ext. 7796
• Manufacturer 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: 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.
• Quantity in Commerce: 27,270 pcs
• Distribution: US 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, IA, PR, MN, LA, AK, HI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.