{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Plymouth",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84109",
      "recalling_firm": "Medivators, Inc.",
      "address_1": "14605 28th Ave N",
      "address_2": "N/A",
      "postal_code": "55447-4822",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Australia, England.",
      "recall_number": "Z-1776-2020",
      "product_description": "Medivators EndoGator REF 100650.  Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scientific Endostat II Irrigation Pump Units.  Contents 10.  Sterile EO.  of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.",
      "product_quantity": "53,790 units total",
      "reason_for_recall": "Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.",
      "recall_initiation_date": "20191009",
      "center_classification_date": "20200423",
      "termination_date": "20201211",
      "report_date": "20200429",
      "code_info": "Lot # / Case UDI#s:   429694 / 2067796406529722070110429694,   429695 / 2067796406529722060110429695,   430357 / 2067796406529722070110430357,   430566 / 2067796406529722070110430566,   432106 / 2067796406529722080110432106,   431602 / 2067796406529722070110431602,   431611 / 2067796400000722070110431611,   431972 / 2067796406529722070110431972,   432728 / 2067796406529722080110432728,   431833 / 2067796406529722080110431833,   432920 / 2067796406529722080110432920,   432919 / 2067796406529722080110432919."
    }
  ]
}