{
  "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": "Buffalo",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "73308",
      "recalling_firm": "Ivoclar Vivadent, Inc.",
      "address_1": "175 Pineview Dr",
      "address_2": "N/A",
      "postal_code": "14228-2231",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide distribution including NY, PA, FL, IN, IA, TX, and CA.",
      "recall_number": "Z-1026-2016",
      "product_description": "Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and  Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant",
      "product_quantity": "Domestic: 406 units",
      "reason_for_recall": "Complaints were received claiming the material failed to polymerize under the curing light.  After investigation, it was determined that a wrong photo-initiator was used in the production batch U30755 of Helioseal Clear.  This failure can lead to incomplete curing of the sealant, if mono-wave LED curing lights are used.",
      "recall_initiation_date": "20160212",
      "center_classification_date": "20160229",
      "termination_date": "20170508",
      "report_date": "20160309",
      "code_info": "REF/Product Code/Art. No. 558521AN, Lot U29336 (exp. 10/5/2020); REF/Product Code/Art. No. 558520AN, Lots U33966, U35661, U50469 (exp. 10/5/2020)"
    }
  ]
}