{"recall":{"id":"fda-device-99879","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"B Braun Medical Inc recalls B Braun SAFSITE Injection Site","firm":"B Braun Medical Inc","date":"2026-09-14","reported":"2026-10-28","status":"Ongoing","classification":"Class II","products":[{"name":"B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.","code":"Catalog Number: 415068; Primary UDI-DI: 04022495769862; Unit of Use UDI-DI: 4045928016067; Lot Number (Expiration Date): 0061968348 (31OCT2029), 0061966913 (30SEP2029).","quantity":"461,300 units","number":"Z-0193-2027","classification":"Class II"}],"reason":"Potential for leakage and backflow at the Safsite valve.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution in the states of CA, FL, IL, IN, MN, NJ, NY, OH, PA, TX, WA and the countries of Australia, Germany Malaysia, New Zealand.","nationwide":true,"states":[],"units":"461,300 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=99879","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"9276759929b29a72","firstSeen":"2026-11-02T22:17:07.772Z","updatedAt":"2026-11-02T22:17:07.772Z","history":[]},"official":{"fetchedAt":"2026-11-02T22:17:07.772Z","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=99879","record":[{"status":"Ongoing","city":"Bethlehem","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99879","recalling_firm":"B Braun Medical Inc","address_1":"824 12th Ave","address_2":"","postal_code":"18018-3524","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the states of CA, FL, IL, IN, MN, NJ, NY, OH, PA, TX, WA and the countries of Australia, Germany Malaysia, New Zealand.","recall_number":"Z-0193-2027","product_description":"B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.","product_quantity":"461,300 units","reason_for_recall":"Potential for leakage and backflow at the Safsite valve.","recall_initiation_date":"20260914","center_classification_date":"20261016","report_date":"20261028","code_info":"Catalog Number: 415068; Primary UDI-DI: 04022495769862; Unit of Use UDI-DI: 4045928016067; Lot Number (Expiration Date): 0061968348 (31OCT2029), 0061966913 (30SEP2029).","more_code_info":""}]}}