{"recall":{"id":"fda-device-99239","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Carl Zeiss Meditec AG recalls Zeiss Intrabeam Spherical Applicator 1","firm":"Carl Zeiss Meditec AG","date":"2026-06-01","reported":"2026-07-08","status":"Ongoing","classification":"Class II","products":[{"name":"Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557","code":"UDI: (01)04049539101563 Batch no: A0002 Serial numbers: US - A63141, A63086 OUS (Outside the US) - A63085, A63096, A63101, A63102, A63105, A63107, A63108, A63109, A63110, A63112, A6313","quantity":"13 units","number":"Z-2649-2026","classification":"Class II"}],"reason":"Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution in the state and territories of Florida and Puerto Rico. The countries of China, Germany, Ecuador, Spain, France, Malaysia, Philippines, Poland, and Romania.","nationwide":true,"states":[],"units":"13 units","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=99239","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"f6fc725a657a22fa","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=99239","record":[{"status":"Ongoing","city":"Oberkochen","state":"N/A","country":"Germany","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99239","recalling_firm":"Carl Zeiss Meditec AG","address_1":"Rudolf-Eber-Str. 11","address_2":"N/A","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the state and territories of Florida and Puerto Rico. The countries of China, Germany, Ecuador, Spain, France, Malaysia, Philippines, Poland, and Romania.","recall_number":"Z-2649-2026","product_description":"Zeiss Intrabeam Spherical Applicator 1.5 cm  REF:304534-6000-557","product_quantity":"13 units","reason_for_recall":"Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.","recall_initiation_date":"20260601","center_classification_date":"20260701","report_date":"20260708","code_info":"UDI: (01)04049539101563 Batch no: A0002  Serial numbers: US - A63141, A63086 OUS (Outside the US) - A63085, A63096, A63101, A63102, A63105, A63107, A63108, A63109, A63110, A63112, A6313"}]}}