{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Marlborough",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63336",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "100 Boston Scientific Way",
      "address_2": "N/A",
      "postal_code": "01752-1234",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Distributed in Brazil, Portugal and Hong Kong.",
      "recall_number": "Z-0080-2013",
      "product_description": "Leveen Coaccess Needle Electrode (3.5/15)  and (4.0/15).     Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.",
      "product_quantity": "19,716 units distributed total",
      "reason_for_recall": "Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in  Portuguese, are incorrect.  all other languages in the  DFU are correct. Consignees  in Brazil, Portugal,and Hong-Kong are being notified.",
      "recall_initiation_date": "20120917",
      "center_classification_date": "20121018",
      "termination_date": "20130717",
      "report_date": "20121024",
      "code_info": "Material Catalog Number: MOO1262230 with lot numbers: 12293473, 12580337, 12639146, 12639181, 12642715,12647752,12651931,12653869, 12656587,  12663028,  12663626, 12667129, 12667787, 12741165, 12760565, 12799352, 12825090, 12849385, 12860811, 12895401,  12967872, 13002918,  13058416,  13096459, 13120668, 13166239,  13235239,  13309477, 13383272, 13399503,  13418415,  13463515,  13498936, 13545732,  13559348,  13665665, 13775008, 13805295,  13822358,  13872667, 13902427, 14076298,  14119776,  14131133,  14169885, 14206936, 14279112, and 14288333.    Material Catalog Number: MOO1262240 with lot numbers: 12341198, 12341781, 12348901, 12351784, 12533460,12533461,12533466,12533467, 12533468, 12600849, 12642716, 12651932, 12663627, 12663628, 12663629, 12667788, 12674036, 12674312, 12741166, 12771577,  12805833, 12805835, 12860812, 12876589, 12937149, 12953904, 12982469, 13020096, 13048075, 13075112, 13117330, 13169619,  13230606,13247208, 13254418, 13278009, 13299117, 13309317, 13352191, 13384075, 13415014,13476371, 13480767, 13545557, 13592399, 13605018, 13610851, 13677260, 13727387,13775007, 13798432, 13813580,  13822357,13837691, 13873878, 13875213, 13883193, 13883196, 13936544, 13940480, 13978762,14076299, 14096255, 14157926, 14169886,14169887, 14217955, and 14249334."
    }
  ]
}