{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Englewood",
      "state": "CO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "65473",
      "recalling_firm": "Steritec Products Mfc. Co., Inc.",
      "address_1": "74 Inverness Drive East",
      "address_2": "N/A",
      "postal_code": "80112-5114",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.",
      "recall_number": "Z-1826-2013",
      "product_description": "Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639    The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers.",
      "product_quantity": "15,300 units",
      "reason_for_recall": "Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.",
      "recall_initiation_date": "20130610",
      "center_classification_date": "20130729",
      "termination_date": "20131219",
      "report_date": "20130807",
      "code_info": "Affected Biological Indicator Lot No.:121101-447 and 121101-444",
      "more_code_info": ""
    }
  ]
}