{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "220606", "product_res_number": "Z-2463-2026", "event_date_initiated": "2026-05-29", "event_date_posted": "2026-06-30", "recall_status": "Open, Classified", "res_event_number": "99028", "product_code": "BZO", "product_description": "Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.", "code_info": "REF/UDI-DI:\n260127/07630002802956, 17630002802953;\n260128/07630002802963, 17630002802960; \n260167/07630002802970, 17630002802977; \n260168/07630002802987, 17630002802984.\n\nLot numbers between 200379 and 205050 (including both.)", "firm_fei_number": "3014766741", "recalling_firm": "Hamilton Medical AG", "address_1": "Parc Industrial Vial 10 10 parc industrial vial", "city": "Domat/Ems", "country": "Switzerland", "additional_info_contact": "Bret Everett\n800-426-6331 Ext. 7796", "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", "root_cause_description": "Component design/selection", "action": "On 5/29/2026, correction notices were emailed to customers who were asked to do the following:\n\n1) Inform all potential users of affected devices within your facility about this issue.\n2) Inform all affected end users and/or sub-distributors and provide them with this notice.\n3) 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.\"\n4) Contact firm if during ventilation or testing an \"exhalation obstructed\" alarm occurs,\nreplace the breathing circuit set as needed.\n- Firm will stay in close contact with the users and provide alternative solutions.\n- See notice for steps that can be taken to overcome membrane adhesion.\n5) Post this notice to ensure all personnel are informed.\n6)Complete and return Facility Reply Form via email to complaints@hamiltonmedical.com \n\nCustomers with questions can contact the firm at the email above.\n\nType of Action to mitigate the risk \nTo mitigate the risk associated with a potentially adhesive expiratory valve membrane, the user is advised to verify unimpeded expiratory gas flow prior to use.\nAfter performing the pre-operative test, ventilate a test lung using the following settings:\nMode: PCV+\nPEEP: 5 mbar\nPcontrol: 5 mbar\nTI: 1 s\nRate: 12 b/min\nIf no \"exhalation obstructed\" alarm is issued, the expiratory valve is safe to use.\nIf 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.", "product_quantity": "27,270 pcs", "distribution_pattern": "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.", "openfda": { "k_number": [ "K932706", "K911328", "K896439", "K952022", "K834569", "K863756", "K830921", "K935582", "K942572", "K873900", "K792268", "K812773", "K893760", "K921510", "K820128", "K932119", "K791469", "K842778", "K903404", "K841378", "K884525", "K834570", "K863910", "K942569", "K830922", "K945740", "K952012", "K810341", "K841722", "K895853", "K861286", "K791856", "K953784", "K844290", "K760993", "K820131", "K813384", "K922479", "K953785", "K882341", "K863033", "K770593", "K952011", "K770581", "K850600", "K932712", "K801087", "K821064", "K874559", "K841637", "K841657", "K791034", "K873927", "K860879", "K812737", "K813155", "K890011", 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"3004488394", "3006897516", "1314417", "3011193444", "3021091708", "3004050971", "3010220595", "3029906224", "3002806988", "3031700059", "3044563261", "3008264065", "2024500", "3011971979", "2518436", "3002808128", "3000126629", "3021244152", "1417592", "3012316249", "3018094310", "3011587055", "3030149975", "3006686250", "3031754334", "3013505405", "3006759904", "3001104093", "1000604079", "3009271244", "3010287621", "3010683054", "3017684630", "3010402691", "3006446479", "3004213967", "3014656749" ], "device_name": "Set, Tubing And Support, Ventilator (W Harness)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5975", "device_class": "1" } } ] }