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. 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.
• 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.