{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "214865", "product_res_number": "Z-2167-2025", "event_date_initiated": "2025-06-26", "event_date_posted": "2025-07-30", "recall_status": "Open, Classified", "res_event_number": "97222", "product_code": "BZO", "product_description": "Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.", "code_info": "UDI-DI: 07630002802963, Lots: 199675, 199676", "firm_fei_number": "3014766741", "recalling_firm": "Hamilton Medical AG", "address_1": "Parc Industrial Vial 10 10 parc industrial vial", "city": "Domat/Ems", "country": "Switzerland", "reason_for_recall": "Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete rebreathing of exhaled gases, which could lead to acute hypercapnia, respiratory acidosis, and if unrecognized organ dysfunction.", "root_cause_description": "Process control", "action": "Starting on 6/26/2025, recall notices were emailed to customers who were asked to do the following:\n\nReturn affected devices.\n\nIf one of the affected breathing circuits would be already in use with a patient, it is requested to exchange it and discard the product after replacement. \n\nIf you are a distributor, please forward to any organization where potentially affected product has been transferred. \n\nComplete and return the acknowledgement form via email to complaints@hamiltonmedical.com\n\nIf you have any questions contact firm at: complaints@hamiltonmedical.com and 800-426-6331", "product_quantity": "2,560", "distribution_pattern": "US Nationwide distribution in the states of NH, NY, CT, PA, IL, ME, 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