{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Norwalk",
      "state": "CT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "76972",
      "recalling_firm": "Mederi Therapeutics, Inc",
      "address_1": "800 Connecticut Ave Ste 1E01",
      "address_2": "N/A",
      "postal_code": "06854-1628",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - Nationwide Distribution and to the countries of: Turkey, Great Britain, Belgium, Kuwait, Poland, Italy, India, China, Costa Rica,  Australia, Malaysia, Jordan and  Egypt.",
      "recall_number": "Z-2050-2017",
      "product_description": "Mederi Stretta Catheter and Accessory Kit, Sterile   For Use with the MEDERI MDRF1 GENERATOR ONLY.  Used in the treatment of gastroesophageal reflux disease (GERD).    REF 175-5580",
      "product_quantity": "1458 units",
      "reason_for_recall": "Product sterility compromised due to breach in sterile barrier package",
      "recall_initiation_date": "20170403",
      "center_classification_date": "20170508",
      "termination_date": "20171010",
      "report_date": "20170517",
      "code_info": "Lot Numbers:   291ST-16  102ST-16  102ST-16R-1  102ST-16R-2  116ST-16R  116ST-16R2  116ST-16R3  116ST-16R4  139ST-16  139ST-16-1  139ST-16-2  139ST-16-3  144ST-16  209ST-16  227ST-16  243ST-16  276ST-15  286ST-16  290ST-16  291ST-16  299ST-16  306ST-16  310ST-15"
    }
  ]
}