{
  "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": "Terminated",
      "city": "Edison",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86674",
      "recalling_firm": "Enterix, Inc.",
      "address_1": "236 Fernwood Ave",
      "address_2": "N/A",
      "postal_code": "08837-3839",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the country of  Australia.",
      "recall_number": "Z-0590-2021",
      "product_description": "InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT)  qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.",
      "product_quantity": "US: 5,256 vials (131,400 test strips); OUS:1051 vials",
      "reason_for_recall": "Product does not meet internal testing criterion; use of the product may result in a potential false positive test result and may lead to patients undergoing unnecessary follow-up diagnostic procedure, i.e., colonoscopy or sigmoidoscopy",
      "recall_initiation_date": "20201008",
      "center_classification_date": "20201215",
      "termination_date": "20230110",
      "report_date": "20201223",
      "code_info": "Lot Numbers: 770G11 and 770G21"
    }
  ]
}