{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Glendora",
      "address_1": "1332 S Lone Hill Ave",
      "reason_for_recall": "A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacement  A/C Power Cord.",
      "address_2": "",
      "product_quantity": "3615 units total",
      "code_info": "Lot/Serial Numbers: 91-17011 to 91-19095; 91-20889 to 91-22339",
      "center_classification_date": "20130614",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and the countries of Australia, Azerbaijan, Belgium, Canada, China, Cyprus, Czech Republic, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Italy, Japan, Kuwait, Latvia, Lebanon, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Romania, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, and United Kingdom.",
      "state": "CA",
      "product_description": "SybronEndo Elements Obturation Unit;  REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy    The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment.",
      "report_date": "20130626",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Ormco/Sybronendo",
      "recall_number": "Z-1544-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "64216",
      "termination_date": "20131107",
      "more_code_info": "",
      "recall_initiation_date": "20130117",
      "postal_code": "91740-5339",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}