{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Schaan",
      "state": "N/A",
      "country": "Liechtenstein",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "72290",
      "recalling_firm": "Ivoclar A. G.",
      "address_1": "Fl-9494",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide Distribution including NJ, PA, SC, FL, IN, IA, WI, IL, MO, TX, CA and WA.",
      "recall_number": "Z-0213-2016",
      "product_description": "Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN.  Dental sealant.  -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag.  Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.",
      "product_quantity": "Domestic: 337 units",
      "reason_for_recall": "A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the formula.  This results in difficulties during extrusion of the material.",
      "recall_initiation_date": "20151007",
      "center_classification_date": "20151104",
      "termination_date": "20160614",
      "report_date": "20151111",
      "code_info": "Lot U12511, Kit Lot U19925 (Helioseal F Assortment only), exp. 11.09.2017"
    }
  ]
}