{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "150228",
      "product_res_number": "Z-0890-2017",
      "event_date_initiated": "2016-10-04",
      "event_date_created": "2016-12-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2018-08-08",
      "res_event_number": "75301",
      "product_code": "FEI",
      "k_numbers": [
        "K062779"
      ],
      "product_description": "Best Practices kits containing certain production lots of Clearify Visualization System\nItem  Code: 21-345\nIntended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens",
      "code_info": "Kit Parent Codes: 00Z2224 00Z2232 00Z2298 00Z2363\t 00Z2364\t 00Z2365 00Z2366\t 00Z2421\t 00Z2425 00Z2430\t 00Z2431\t 00Z2460 00Z2493\t\t 00Z2534\t\t 00Z2535\t\t 000Z2544\t 00Z5000B\t 00Z5001B\t GYNKIT2",
      "firm_fei_number": "1219930",
      "recalling_firm": "Medtronic",
      "address_1": "60 Middletown Ave",
      "city": "North Haven",
      "state": "CT",
      "postal_code": "06473-3908",
      "reason_for_recall": "Product sterility is compromised due to breach of the sterile barrier",
      "root_cause_description": "Employee error",
      "action": "Covidien issued an Urgent Medical Device Recall letter on October 4, 2016 and a corrected letter on October 10, 2016 to US Customers via Federal Express.   The letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Disposition of product within Medtronic control and customer returned devices will be reworked.\nQuestions or concerns, contact your Medtronic representative or customer service at 800-882-5878.",
      "product_quantity": "230 systems",
      "distribution_pattern": "Worldwide Distribution - US (Nationwide)\nForeign:\nAustria\nBelgium\nBulgaria\nBrazil\nChile\nCyprus\nDenmark\nEgypt\nFinland\nFrance\nFrance\nGermany\nGreece\nHungary\nIran\nIreland\nIsrael\nItaly\nJapan\nKenya\nKuwait\nLatvia\nLuxembourg\nMexico\nNamibia\nNetherlands\nNigeria\nNorway\nPoland\nPortugal\nRomania\nSaudi Arabia\nSerbia\nSlovakia\nSouth Africa\nSpain\nSweden\nSwitzerland\nTurkey\nUnited Arab Emirates\nUnited Kingdom",
      "openfda": {
        "device_name": "Instrument, Special Lens, For Endoscope",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "1",
        "registration_number": [
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          "3016851379",
          "3012470322",
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          "3033043422",
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          "2020550",
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        ],
        "fei_number": [
          "1643264",
          "3005747797",
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          "3006696607",
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          "3033043422",
          "3014262693",
          "3004216008",
          "2020550",
          "1220246",
          "3015972835"
        ],
        "k_number": [
          "K873795",
          "K862872"
        ]
      }
    }
  ]
}