{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "122437",
      "product_res_number": "Z-0150-2014",
      "event_date_initiated": "2013-09-30",
      "event_date_posted": "2013-11-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-03-26",
      "res_event_number": "66465",
      "product_code": "LTI",
      "pma_numbers": [
        "P070009"
      ],
      "product_description": "Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids.\n\nProduct Usage:\nIntended for use in surgical treatment of morbid obesity",
      "code_info": "The following product code and lot numbers were affected by this recall: Product Codes: 2200-X Lot Numbers:  ZLGBC5, ZLNBCW, ZLNBJC, ZLPBB9, ZMBBBB, ZMCBBC, ZMGBCJ, ZMHBBT, ZMHBCV, ZMLBD0, ZMMBCD, ZMPBBC, ZNCBC6, ZNGBB3, and ZNGBBF.",
      "firm_fei_number": "1527736",
      "recalling_firm": "Ethicon Endo-Surgery Inc",
      "address_1": "4545 Creek Rd",
      "city": "Cincinnati",
      "state": "OH",
      "postal_code": "45242-2803",
      "additional_info_contact": "Thomas A. Morris\n513-337-3419",
      "reason_for_recall": "During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "Ethicon sent an Urgent: Medical Device Recall letter dated September 30, 2013 to affected consignees via overnight, UPS to allow tracking of the receipt.  The letter identified affected products, problem and actions to be taken.  Each consignee is requested to respond to a provided Business Reply Form (BRF), indicating whether they have affected product, how much and whether they will/have returned the product or whether they no longer have any of the recall product.  For questions contact your local sales representative or call our Customer Support Center 1-877-384-4266 option 6.",
      "product_quantity": "Product Code: 2200-X - 2,475 units",
      "distribution_pattern": "Worldwide Distribution: USA (nationwide) including the states of: Alabama, Connecticut, Indiana, Michigan, North Carolina, South Carolina, Alaska, Delaware, Kansas, Minnesota, Ohio, Tennessee, Arizona, Florida, Kentucky, Mississipp,i Oklahoma, Texas, Arkansas, Georgia, Louisiana, Nebraska, Oregon, Virginia, California, Idaho, Maryland, Nevada, Pennsylvania, Washington, Colorado, Illinois, Massachusetts, New Jersey, Rhode Island, and West Virginia; and the countries of: Argentina, France, Malaysia, Spain, Australia, Georgia, Martinique, Sweden, Belgium, Germany, Mexico, Switzerland, Brazil, Greece, Netherland, Taiwan, Chile, Hungary, Panama, Tunisia, China, India, Philippines, United Arab Emirates, Czech Republic, Israel, Poland, United Kingdom, Egypt, Italy, Portugal, Venezuela, Estonia, Kenya, Russia, Finland, Kuwait, and Saudi Arabia.",
      "openfda": {
        "pma_number": [
          "P140008",
          "P180024",
          "P160001",
          "P250023",
          "P190012",
          "P140012",
          "P070009",
          "P840025",
          "P000008"
        ],
        "registration_number": [
          "1222928",
          "3013508647",
          "3003744503",
          "3000296634",
          "2025182",
          "1220477",
          "1018470",
          "3005099803",
          "3012638928",
          "3007695959",
          "3011299930"
        ],
        "fei_number": [
          "3013508647",
          "3003744503",
          "3000296634",
          "2025182",
          "3015409025",
          "1220477",
          "1018470",
          "3005099803",
          "1000120613",
          "3007695959",
          "3011299930"
        ],
        "device_name": "Implant, Intragastric For Morbid Obesity",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}