{
  "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": [
    {
      "status": "Terminated",
      "city": "South Bend",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "68223",
      "recalling_firm": "Heraeus Kulzer, LLC.",
      "address_1": "300 Heraeus Dr",
      "address_2": "N/A",
      "postal_code": "46614-2557",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution in the states of GA, TX, IL, CA, WA, WI, HI, MO, FL, NJ, TN, PA, NY, NC, OH, IN, CT, KY, AZ, NV, IA,",
      "recall_number": "Z-1651-2014",
      "product_description": "Gluma Desensitizer Power Gel    Product Usage:  Usage:  This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of teeth to receive fixed prosthesis or restorations.",
      "product_quantity": "5,112 syringes or 1,278 kits (1 Kit=4 syringes)",
      "reason_for_recall": "The firm discovered that the Gluma Desensitizer Power Gel can be inadvertently extruded from the application syringe all at once when it is supposed to extrude on the desired area a small amount at a  time. If extruded all at once, product could reach the dental patients mucosa, face or eyes or the dental professional could be exposed. This would cause irritation, burning or blistering.",
      "recall_initiation_date": "20140423",
      "center_classification_date": "20140522",
      "termination_date": "20141105",
      "report_date": "20140528",
      "code_info": "Model Number(s): 66043451  Expiry: 2015-09  Syringe Lot number 010103, which are contained within Kit lot numbers  42.43.44.45.46.47.48.49,50, and 51.     Note; lots 49 and 50 were captured in house, 0 was distributed. Lot 51 was made by the manufacturer, however, never received by us or distributed."
    }
  ]
}