{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Waltham",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91154",
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "address_1": "920 Winter St Bld 950",
      "address_2": "",
      "postal_code": "02451-1521",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-0734-2023",
      "product_description": "2008T and 2008TBluestar Hemodialysis Machines with  CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility  Models:  (1) 190713  2008T HEMODIALYSIS SYS., with CDX;  (2) 190766  2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ;                           (3)  191124  2008T HD SYS. CDX BLUESTAR;      (4) 191126  2008T HD SYS. CDX W/BIBAG BLUESTAR",
      "product_quantity": "2008T with CDX= 70,552  2008T Bluestar with CDX= 25,205",
      "reason_for_recall": "(1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false alarm \"Remove USB 2 Device\".",
      "recall_initiation_date": "20220727",
      "center_classification_date": "20221220",
      "report_date": "20221228",
      "code_info": "Software issue in SW versions 2.72 and earlier with CDX. UDI: (1) 00840861100897; (2) 00840861100910; (3) 00840861102082; (4) 00840861102099",
      "more_code_info": ""
    }
  ]
}