{"recall":{"id":"fda-device-99556","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 4 products","firm":"Fresenius Medical Care Renal Therapies Group, LLC","date":"2026-08-10","reported":"2026-09-09","status":"Ongoing","classification":"Class II","products":[{"name":"5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6","code":"Lots 25KR01227 25NR01257 UDI-DI 00840861102556","quantity":"120 units","number":"Z-3084-2026","classification":"Class II"},{"name":"5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3","code":"Lots 25JR01800 25KR01224 25LR01001 25NR01018 25NR01272 25PR01077 25PR01219 25PR01220 UDI-DI 00840861102518","quantity":"62,544 units","number":"Z-3085-2026","classification":"Class II"},{"name":"5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C","code":"Lots 25JR01801 25KR01225 25KR01251 25NR01016 25NR01265 UDI-DI 00840861102532","quantity":"18,600","number":"Z-3086-2026","classification":"Class II"},{"name":"5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8","code":"Lots 25JR01802 25NR01017 25NR01266 UDI-DI 00840861102525","quantity":"6,624 units","number":"Z-3087-2026","classification":"Class II"}],"reason":"Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NH, NY, OH, PA, TN, TX, VA and the country of Lithuania.","nationwide":true,"states":[],"units":"120 units; 62,544 units; 18,600; 6,624 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=99556","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"25436698ad890287","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=99556","record":[{"status":"Ongoing","city":"Waltham","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99556","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":"N/A","distribution_pattern":"Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NH, NY, OH, PA, TN, TX, VA and the country of Lithuania.","recall_number":"Z-3084-2026","product_description":"5008X Standard HD Pre-Flush    Standard Blood Tubing Set    Part Number 03-5110-6","product_quantity":"120 units","reason_for_recall":"Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.","recall_initiation_date":"20260810","center_classification_date":"20260902","report_date":"20260909","code_info":"Lots 25KR01227 25NR01257  UDI-DI 00840861102556","more_code_info":""},{"status":"Ongoing","city":"Waltham","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99556","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":"N/A","distribution_pattern":"Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NH, NY, OH, PA, TN, TX, VA and the country of Lithuania.","recall_number":"Z-3085-2026","product_description":"5008X HD/HDF   Standard Blood  Tubing Set    Part Number 03-5300-3","product_quantity":"62,544 units","reason_for_recall":"Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.","recall_initiation_date":"20260810","center_classification_date":"20260902","report_date":"20260909","code_info":"Lots 25JR01800 25KR01224 25LR01001 25NR01018 25NR01272 25PR01077 25PR01219 25PR01220  UDI-DI 00840861102518","more_code_info":""},{"status":"Ongoing","city":"Waltham","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99556","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":"N/A","distribution_pattern":"Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NH, NY, OH, PA, TN, TX, VA and the country of Lithuania.","recall_number":"Z-3086-2026","product_description":"5008X HD/HDF   with CLiC Blood  Tubing Set    Part number 03-5300-3C","product_quantity":"18,600","reason_for_recall":"Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.","recall_initiation_date":"20260810","center_classification_date":"20260902","report_date":"20260909","code_info":"Lots 25JR01801 25KR01225 25KR01251 25NR01016 25NR01265  UDI-DI 00840861102532","more_code_info":""},{"status":"Ongoing","city":"Waltham","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99556","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":"N/A","distribution_pattern":"Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NH, NY, OH, PA, TN, TX, VA and the country of Lithuania.","recall_number":"Z-3087-2026","product_description":"5008X HD/HDF   with Twister Blood  Tubing Set    Part Number 03-5350-8","product_quantity":"6,624 units","reason_for_recall":"Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.","recall_initiation_date":"20260810","center_classification_date":"20260902","report_date":"20260909","code_info":"Lots 25JR01802 25NR01017 25NR01266  UDI-DI 00840861102525","more_code_info":""}]}}