{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Shoreview",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79822",
      "recalling_firm": "Torax Medical, Inc.",
      "address_1": "4188 Lexington Ave N",
      "address_2": "N/A",
      "postal_code": "55126-6106",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) in states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY; and in countries of: Austria, France, Germany, Italy, Scotland, Spain, Switzerland, United Kingdom.",
      "recall_number": "Z-2041-2018",
      "product_description": "LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx, sterile, Rx only.  Labeled as:    a. Product Code LXM-13;    b. Product Code LXM-14;   c. Product Code LXM-15;    d. Product Code LXM-16;       Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD.",
      "product_quantity": "9,131 devices in total",
      "reason_for_recall": "Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.",
      "recall_initiation_date": "20180420",
      "center_classification_date": "20180531",
      "termination_date": "20201104",
      "report_date": "20180606",
      "code_info": "a. Product Code LXM-13, Part No. 4549-13, GTIN 00855106005394;   b. Product Code LXM-14, Part No. 4549-14, GTIN 00855106005400;    c. Product Code LXM-15, Part No. 4549-15, GTIN 00855106005417;    d. Product Code LXM-16, Part No. 4549-16, GTIN 00855106005424;         Lot No. 6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557"
    }
  ]
}