{
  "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": "Redmond",
      "state": "WA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "64395",
      "recalling_firm": "Endogastric Solutions Inc",
      "address_1": "8210 154th Ave NE",
      "address_2": "N/A",
      "postal_code": "98052-3877",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution including NC, VA, WI, TN, KY, IN, FL, MI, IA, IL, TX, LA, AR, HI, CA, NV, OR, and WA,",
      "recall_number": "Z-1136-2013",
      "product_description": "EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01.  Label reads in part \"EsophyX2 2-LINK Device Qty:  (1) Fastener Delivery System ***\"    Designed for the treatment of Gastroesophageal Reflux Disease (GERD), with erosive and non-erosive esophagitis",
      "product_quantity": "190",
      "reason_for_recall": "EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.",
      "recall_initiation_date": "20130204",
      "center_classification_date": "20130417",
      "termination_date": "20130702",
      "report_date": "20130424",
      "code_info": "Lots 401378, 401392, 401409, and 401416  Additional lots manufactured from 11/26/12 to 12/07/12 had a stop ship issued issued on 11/21/12 and the product was placed in quarantine (it was not distributed).  This represents an additional 175 units from a total of 187 units manufactured during this time period.  12 units were used for bench testing.  The lot numbers of units in quarantine are 401432, 401434, 401436, and 401441."
    }
  ]
}