{"url_path":"/fda/device/recalls/Z-2463-2026","section_key":"summary","section_title":"DEVICE Recall: Hamilton Medical AG — Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-29","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2463-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Hamilton Medical AG"},"word_count":173,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2463-2026\n\n**Recalling firm:** Hamilton Medical AG\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-29\n**Report date:** 2026-07-08\n\n## Product\nBreathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.\n\n## Reason\nVentilator 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\n\n## Affected lots\nREF/UDI-DI: 260127/07630002802956, 17630002802953; 260128/07630002802963, 17630002802960;   260167/07630002802970, 17630002802977;  260168/07630002802987, 17630002802984.  Lot numbers between 200379 and 205050 (including both.)\n\n## Distribution\nUS 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."}