{"recall":{"id":"fda-device-99573","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Nipro Renal Soultions USA, Corporation recalls 4 products","firm":"Nipro Renal Soultions USA, Corporation","date":"2026-08-05","reported":"2026-09-16","status":"Ongoing","classification":"Class II","products":[{"name":"MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201","code":"BC-100 - Lot:N4L022 (exp.11/13/2026), N4L037(exp.11/18/2026) BC+201- Lot: N4L010(exp.11/06/2026)","quantity":"3,286 cases","number":"Z-3133-2026","classification":"Class II"},{"name":"MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))","code":"DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026)","quantity":"2,327 cases","number":"Z-3134-2026","classification":"Class II"},{"name":"Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25","code":"DCA+200-25 : Lots - NDC5E015(Exp.5/20/2027), NDC5E016(Exp.5/21/2027), NDC5E017(Exp.5/22/2027), NDC5E019(Exp.5/29/2027), NDC5E012(Exp.5/19/2027), NDC5B017(Exp.2/24/2027), NDC5C023(Exp.3/24/2027) DCA+203-25: NDC5C026(Exp.3/27/2027), NDC5L026(Exp.11/17/2027)","quantity":"7,770 cases","number":"Z-3135-2026","classification":"Class II"},{"name":"Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)","code":"LC+200-D: Lot-N4J030 (Exp.9/20/2026), N5D043(Exp.4/16/2027); LC+225: Lot-N6A025(Exp.1/8/2028)","quantity":"100 drums/1072 cases","number":"Z-3136-2026","classification":"Class II"}],"reason":"Hemodialysis concentrates contain high endotoxin levels","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.","nationwide":true,"states":[],"units":"3,286 cases; 2,327 cases; 7,770 cases; 100 drums/1072 cases","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=99573","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"900c26e8c97e31bf","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=99573","record":[{"status":"Ongoing","city":"Lewisberry","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99573","recalling_firm":"Nipro Renal Soultions USA, Corporation","address_1":"509 Fishing Creek Rd","address_2":"","postal_code":"17339-9517","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.","recall_number":"Z-3133-2026","product_description":"MedicaLyte Liquid Bicarbonate Concentrate    REF: BC-100 and BC+201","product_quantity":"3,286 cases","reason_for_recall":"Hemodialysis concentrates contain high endotoxin levels","recall_initiation_date":"20260805","center_classification_date":"20260910","report_date":"20260916","code_info":"BC-100 - Lot:N4L022 (exp.11/13/2026), N4L037(exp.11/18/2026) BC+201- Lot: N4L010(exp.11/06/2026)","more_code_info":""},{"status":"Ongoing","city":"Lewisberry","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99573","recalling_firm":"Nipro Renal Soultions USA, Corporation","address_1":"509 Fishing Creek Rd","address_2":"","postal_code":"17339-9517","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.","recall_number":"Z-3134-2026","product_description":"MedicaLyte Bicarbonate Powder    REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))","product_quantity":"2,327 cases","reason_for_recall":"Hemodialysis concentrates contain high endotoxin levels","recall_initiation_date":"20260805","center_classification_date":"20260910","report_date":"20260916","code_info":"DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026)","more_code_info":""},{"status":"Ongoing","city":"Lewisberry","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99573","recalling_firm":"Nipro Renal Soultions USA, Corporation","address_1":"509 Fishing Creek Rd","address_2":"","postal_code":"17339-9517","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.","recall_number":"Z-3135-2026","product_description":"Citric Complete Dry Citric Acid Concentrate    REF: DCA+200-25 & DCA+203-25","product_quantity":"7,770 cases","reason_for_recall":"Hemodialysis concentrates contain high endotoxin levels","recall_initiation_date":"20260805","center_classification_date":"20260910","report_date":"20260916","code_info":"DCA+200-25 : Lots - NDC5E015(Exp.5/20/2027), NDC5E016(Exp.5/21/2027), NDC5E017(Exp.5/22/2027), NDC5E019(Exp.5/29/2027), NDC5E012(Exp.5/19/2027), NDC5B017(Exp.2/24/2027), NDC5C023(Exp.3/24/2027) DCA+203-25: NDC5C026(Exp.3/27/2027), NDC5L026(Exp.11/17/2027)","more_code_info":""},{"status":"Ongoing","city":"Lewisberry","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99573","recalling_firm":"Nipro Renal Soultions USA, Corporation","address_1":"509 Fishing Creek Rd","address_2":"","postal_code":"17339-9517","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.","recall_number":"Z-3136-2026","product_description":"Citric Complete Liquid Citric Acid Concentrate    REF: LC+200-D,LC+201, LC+225(45X)","product_quantity":"100 drums/1072 cases","reason_for_recall":"Hemodialysis concentrates contain high endotoxin levels","recall_initiation_date":"20260805","center_classification_date":"20260910","report_date":"20260916","code_info":"LC+200-D: Lot-N4J030 (Exp.9/20/2026), N5D043(Exp.4/16/2027); LC+225: Lot-N6A025(Exp.1/8/2028)","more_code_info":""}]}}