{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Completed",
      "city": "Waltham",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86537",
      "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": "Distributed nationwide throughout the U.S and Puerto Rico.  9,907 devices currently in the field.  361 devices have been deactivated.  4,870 devices are ready to be shipped to customers along with the Urgent Medical Device Correction notice and response form.",
      "recall_number": "Z-0439-2021",
      "product_description": "Liberty Select Cycler  Software Version 2.9.0  Model Number 180343 and RTLR180343",
      "product_quantity": "9,907 devices",
      "reason_for_recall": "The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and the cycler does not recognize the extra fluid is present and it will not make it available for treatment. Not having enough solution to complete treatment may lead to inadequate dialysis which could result in the accumulation of toxins and fluid. Symptoms may include shortness of breath, increased weight gain, and increased blood pressure.",
      "recall_initiation_date": "20200912",
      "center_classification_date": "20201107",
      "report_date": "20201118",
      "code_info": "All Liberty Select Cyclers with Software Version 2.9.0  Model Number 180343 and RTLR180343",
      "more_code_info": ""
    }
  ]
}