{
  "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": "2026-04-22",
    "results": {
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  "results": [
    {
      "country": "United States",
      "city": "Medina",
      "address_1": "711 Park Ave",
      "reason_for_recall": "Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum Infusion Pump System because it may result in a facility drug library that does not represent common clinical practices.",
      "address_2": "",
      "product_quantity": "2,048 CD's",
      "code_info": "All versions",
      "center_classification_date": "20120718",
      "distribution_pattern": "Worldwide Distribution -  US (nationwide) including Puerto Rico, and Canada.",
      "state": "NY",
      "product_description": "SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software.      Product Usage:  A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.",
      "report_date": "20120725",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Sigma",
      "recall_number": "Z-2030-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "61691",
      "termination_date": "20180705",
      "more_code_info": "",
      "recall_initiation_date": "20120423",
      "postal_code": "14103-1036",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
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