{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Edison",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97802",
      "recalling_firm": "Enterix, Inc.",
      "address_1": "236 Fernwood Ave",
      "address_2": "",
      "postal_code": "08837-3839",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Nevada, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, Washington, West Virginia and the country of Philippines.",
      "recall_number": "Z-0725-2026",
      "product_description": "InSure ONE Fecal Immunochemical Test. Labeled as follows:    1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010.    2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025.    3. InSure ONE POL Combo Pack. Model Number: 90030.    InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples.",
      "product_quantity": "201,426 test kits",
      "reason_for_recall": "InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.",
      "recall_initiation_date": "20250917",
      "center_classification_date": "20251128",
      "report_date": "20251210",
      "code_info": "1. Model Number: 90010; GTIN:10850093003313; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102.   2. Model Number: 90025; GTIN: 20850093003310; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102.   3. Model Number: 90030; GTIN: 00850093003279; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102.",
      "more_code_info": ""
    }
  ]
}