{
  "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": "Somerville",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63254",
      "recalling_firm": "Ethicon, Inc.",
      "address_1": "US Highway 22 West",
      "address_2": "N/A",
      "postal_code": "08876",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution -- USA (nationwide) and the countries of  Canada, European Union, Singapore, Israel, Mexico and Brazil.",
      "recall_number": "Z-0111-2013",
      "product_description": "EVICEL Fibrin Sealant (Human) Rx Only.      Manufacturer:  Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603.      Distributed by:  Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA.      The Pressure Regulator System is positioned on the floor or on an IV pole and accepts medical gas (compressed air, nitrogen, CO2) from the central hospital system or from medical gas cylinders.",
      "product_quantity": "4800 pressure regulators distributed worldwide; 1500 distributed within the US",
      "reason_for_recall": "Ethicon and Omrix Biopharmaceuticals have received reports of air or gas embolism occuring in association with the use of spray devices employing a pressure regulator to administer EVICEL; these events appear to be related to the use of the spray device at higher-than-recommended pressures and/or in close proximity to the tissue surface.  The field correction initiated is to provide the recommend",
      "recall_initiation_date": "20120702",
      "center_classification_date": "20121022",
      "termination_date": "20150915",
      "report_date": "20121031",
      "code_info": "To include all lots and product codes for EVICEL and Omrix pressure regulators."
    }
  ]
}