{
  "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": "84866",
      "product_res_number": "Z-0830-2011",
      "event_date_initiated": "2009-08-20",
      "event_date_posted": "2010-12-28",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-01-03",
      "res_event_number": "53183",
      "product_code": "FAT",
      "k_numbers": [
        "K983220"
      ],
      "product_description": "Stryker Infravision Esophageal Kit, Model Numbers 220180548, 220180540, 220180560, manufactured by Stryker Endoscopy San Jose.",
      "code_info": "5687,5766,5815,5822,5833,5872, 5924,60973888,60987814, 61004943, STROll409-l, STROl1409-2, STRO 11609-1, STROl1609-2, STR02l009-1, STR02l009-8, STR022709-l, STR022709-2, STR03ll09-1, STR03ll09-3, STR040l09-l, STR041709-2, STR041709-4, STR0430009-2, STRlO0208-l, STR102208-1, STR102408-l, STRI02708-7, STR103l08-1, STRlll308-l, STR12l808-l, STR12l808-2, STROl1209-l",
      "firm_fei_number": "2936485",
      "recalling_firm": "Stryker Endoscopy",
      "address_1": "5900 Optical Ct",
      "city": "San Jose",
      "state": "CA",
      "postal_code": "95138-1400",
      "additional_info_contact": "Nila Patel \n408-754-2124",
      "reason_for_recall": "The silicone sheath component of the product detaches from the catheter during removal of the e-kit from the body.",
      "root_cause_description": "Device Design",
      "action": "Stryker issued Urgent Product Recall letters dated August 20, 2009 to all its direct consignees, informing them of the affected products and providing instructions on the recall. Customers were requested to return the affected product to Styrker.",
      "product_quantity": "2985 units",
      "distribution_pattern": "Worldwide Distribution: USA in the states of: Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, \nMinnesota, Missouri, North Carolina, New Hampshire, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West  Virginia, and Wyoming, and the countries/region of Australia, Canada, Scandinavia, Italy, and Switzerland.",
      "openfda": {
        "k_number": [
          "K972119",
          "K133439",
          "K843186",
          "K780471",
          "K983220",
          "K901425",
          "K960173",
          "K842679"
        ],
        "device_name": "Bougie, Esophageal, And Gastrointestinal, Gastro-Urology",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5365",
        "device_class": "2",
        "registration_number": [
          "3010041511",
          "2183446",
          "3023657851",
          "3010612620",
          "3011137372",
          "3006750742",
          "3004365956",
          "3026671998",
          "3013526170"
        ],
        "fei_number": [
          "3010041511",
          "2183446",
          "3023657851",
          "3010612620",
          "3006750742",
          "3005747797",
          "3004365956",
          "3026671998",
          "3013526170"
        ]
      }
    }
  ]
}