{"recall":{"id":"fda-device-99028","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Hamilton Medical AG recalls Breathing circuit set","firm":"Hamilton Medical AG","date":"2026-05-29","reported":"2026-07-08","status":"Ongoing","classification":"Class I","products":[{"name":"Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.","code":"REF/UDI-DI: 260127/07630002802956, 17630002802953; 260128/07630002802963, 17630002802960; 260167/07630002802970, 17630002802977; 260168/07630002802987, 17630002802984. Lot numbers between 200379 and 205050 (including both.)","quantity":"27,270 pcs","number":"Z-2463-2026","classification":"Class I"}],"reason":"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","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"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.","nationwide":true,"states":[],"units":"27,270 pcs","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99028","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"0ebdff90498917ac","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99028","record":[{"status":"Ongoing","city":"Domat/Ems","state":"N/A","country":"Switzerland","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99028","recalling_firm":"Hamilton Medical AG","address_1":"Parc Industrial Vial 10","address_2":"N/A","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","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.","recall_number":"Z-2463-2026","product_description":"Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.","product_quantity":"27,270 pcs","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","recall_initiation_date":"20260529","center_classification_date":"20260630","report_date":"20260708","code_info":"REF/UDI-DI: 260127/07630002802956, 17630002802953; 260128/07630002802963, 17630002802960;   260167/07630002802970, 17630002802977;  260168/07630002802987, 17630002802984.  Lot numbers between 200379 and 205050 (including both.)"}]}}