{
  "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": "Alvear",
      "state": "",
      "country": "Argentina",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93625",
      "recalling_firm": "TERRAGENE S.A.",
      "address_1": "Ruta Nacional N 9, Km 280, Cp 2130",
      "address_2": "Parque Industrial Micropi",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.",
      "recall_number": "Z-0836-2024",
      "product_description": "Terragene Integron IT26-C    Terragene Integron IT26-C with extender    Benco Dental Chemical Integrator [5726-583]    Tuttnauer (WTL198-0082)    Terragene Integron (PCD26-C)    Terragene Bionova PCD (PCD222-C)",
      "product_quantity": "36,857 strips",
      "reason_for_recall": "Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.",
      "recall_initiation_date": "20231207",
      "center_classification_date": "20240126",
      "report_date": "20240207",
      "code_info": "Product Number: IT26-C UDI-DI code: 07798164679622 Lot Numbers: 19033 19038 19039 19040 19057 19105-12 19105-16 B10400-13 B10400-14 B10400-16 B10400-21 B10400-23 19105-23 19105-24 B10519 B10555 B10625 B10627 B10628 B10629 B20040 B20043 B30012 B30013 B30110 B30111 B30112  Product Number: IT26-C with extender UDI-DI code: 07798164678656 Lot Numbers: 19059 B10572 B30068 B30110  Product Number: Terragene Integron (PCD26-C) UDI-DI code: 07798164679370 Lot Numbers: 100320 110320 220620 F10009 F20026 F20079 F20084  Product Number: Benco Dental Chemical Integrator 5726-583 UDI-DI code: 00366975058768 Lot Numbers: 131120-8 131120-1 131120-2 131120-4 131120-7 131120-5 131120-11 131120-3 131120-16 131120-15 131120-12 131120-19 131120-10 131120-6 131120-18 131120-17 131120-14 131120-13 131120-9 B10540 B20039 B20185 B20576 B30010 B30138  Product Number: Tuttnauer (WTL198-0082) UDI-DI code: 07798164677888 Lot Numbers: 120320 170920-3 170920-2 170920-1 170920-8 170920-7 170920-6 170920-5 170920-4 B10331-1 B10331-2 B10331-3 B10539 B20679",
      "more_code_info": ""
    }
  ]
}