{"recall":{"id":"fda-device-99543","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Fresenius Medical Care Renal Therapies Group, LLC recalls 3 products","firm":"Fresenius Medical Care Renal Therapies Group, LLC","date":"2026-07-14","reported":"2026-09-09","status":"Ongoing","classification":"Class II","products":[{"name":"GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis","code":"1) 0FD2251-3B, UDI/DI 00840861101535, Lot Numbers: 26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009; 2) 0FD3251-3B, UDI/DI 00840861101597, Lot Numbers: 26AXGF014, 26AXGF018.","quantity":"27,216 cs; 2,316 ea","number":"Z-3091-2026","classification":"Class II"},{"name":"NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for Bicarbonate Hemodialysis","code":"1) 08-1251-1, UDI/DI 00840861101658, Lot Numbers: 26AXAC056; 2) 08-2251-0, UDI/DI 00840861101696, Lot Numbers: 26AXAC050, 26BXAC012, 26BXAC042; 3) 08-2301-3, UDI/DI 00840861101702, Lot Numbers: 26BXAC013, 26BXAC045; 3) 08-3251-9, UDI/DI 00840861101740, Lot Numbers: 26AXAC051, 26BXAC011, 26BXAC043; 4) 08-3301-2, UDI/DI 00840861101757, Lot Numbers: 26AXAC052; 5) 13-2201-5, UDI/DI 00840861101849, Lot Numbers: 26AXAC062, 26AXAC064; 6) 13-2251-0, UDI/DI 00840861101863, Lot Numbers: 26AXAC041, 26AXAC058, 26AXAC059, 26AXAC065, 26BXAC001, 26BXAC003, 26BXAC005, 26BXAC034, 26BXAC049, 26BXAC051; 7) 13-3251-9, UDI/DI 00840861101887, Lot Numbers: 26BXAC037, 26BXAC048.","quantity":"2,998 cs; 68 ea","number":"Z-3092-2026","classification":"Class II"},{"name":"Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis","code":"1) 08-2251-CA, UDI/DI 00840861101344, Lot Numbers: 26BXAC038; 2) 08-3251-CA, UDI/DI 00840861101351, Lot Numbers: 26BXAC039; 3) 13-2251-CA, UDI/DI 00840861101375, Lot Numbers: 26BXAC040, 26BXAC041.","quantity":"56,036 cs; 1,788 drums; 204 ea","number":"Z-3093-2026","classification":"Class II"}],"reason":"Complaints of blue-green discoloration in product","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide distribution - US Nationwide and the country of Mexico.","nationwide":true,"states":[],"units":"27,216 cs; 2,316 ea; 2,998 cs; 68 ea; 56,036 cs; 1,788 drums; 204 ea","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=99543","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"bb4b694d7ead76ee","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=99543","record":[{"status":"Ongoing","city":"Waltham","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99543","recalling_firm":"Fresenius Medical Care Renal Therapies Group, LLC","address_1":"920 Winter St Bld 920","address_2":"N/A","postal_code":"02451-1521","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the country of Mexico.","recall_number":"Z-3091-2026","product_description":"GRANUFLO Dry Acid Concentrate:  Product Numbers:  0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis","product_quantity":"27,216 cs; 2,316 ea","reason_for_recall":"Complaints of blue-green discoloration in product","recall_initiation_date":"20260714","center_classification_date":"20260903","report_date":"20260909","code_info":"1) 0FD2251-3B, UDI/DI 00840861101535, Lot Numbers:  26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009;  2) 0FD3251-3B, UDI/DI 00840861101597, Lot Numbers:  26AXGF014, 26AXGF018.","more_code_info":""},{"status":"Ongoing","city":"Waltham","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99543","recalling_firm":"Fresenius Medical Care Renal Therapies Group, LLC","address_1":"920 Winter St Bld 920","address_2":"N/A","postal_code":"02451-1521","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the country of Mexico.","recall_number":"Z-3092-2026","product_description":"NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis:  Product Numbers:  08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for Bicarbonate Hemodialysis","product_quantity":"2,998 cs; 68 ea","reason_for_recall":"Complaints of blue-green discoloration in product","recall_initiation_date":"20260714","center_classification_date":"20260903","report_date":"20260909","code_info":"1) 08-1251-1, UDI/DI 00840861101658, Lot Numbers:  26AXAC056;  2) 08-2251-0, UDI/DI 00840861101696, Lot Numbers:  26AXAC050, 26BXAC012, 26BXAC042;  3) 08-2301-3, UDI/DI 00840861101702, Lot Numbers:  26BXAC013, 26BXAC045;  3) 08-3251-9, UDI/DI 00840861101740, Lot Numbers:  26AXAC051, 26BXAC011, 26BXAC043;  4) 08-3301-2, UDI/DI 00840861101757, Lot Numbers:  26AXAC052;  5) 13-2201-5, UDI/DI 00840861101849, Lot Numbers:  26AXAC062, 26AXAC064;  6) 13-2251-0, UDI/DI 00840861101863, Lot Numbers:  26AXAC041, 26AXAC058, 26AXAC059, 26AXAC065, 26BXAC001, 26BXAC003, 26BXAC005, 26BXAC034, 26BXAC049, 26BXAC051;   7) 13-3251-9, UDI/DI 00840861101887, Lot Numbers:  26BXAC037, 26BXAC048.","more_code_info":""},{"status":"Ongoing","city":"Waltham","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99543","recalling_firm":"Fresenius Medical Care Renal Therapies Group, LLC","address_1":"920 Winter St Bld 920","address_2":"N/A","postal_code":"02451-1521","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the country of Mexico.","recall_number":"Z-3093-2026","product_description":"Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis:  Product Numbers:  08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis","product_quantity":"56,036 cs; 1,788 drums; 204 ea","reason_for_recall":"Complaints of blue-green discoloration in product","recall_initiation_date":"20260714","center_classification_date":"20260903","report_date":"20260909","code_info":"1) 08-2251-CA, UDI/DI 00840861101344, Lot Numbers:  26BXAC038;  2) 08-3251-CA, UDI/DI 00840861101351, Lot Numbers:  26BXAC039;  3) 13-2251-CA, UDI/DI 00840861101375, Lot Numbers:  26BXAC040, 26BXAC041.","more_code_info":""}]}}