{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "219347",
      "product_res_number": "Z-2209-2026",
      "event_date_initiated": "2026-03-23",
      "event_date_posted": "2026-05-15",
      "recall_status": "Open, Classified",
      "res_event_number": "98654",
      "product_code": "FBN",
      "k_numbers": [
        "K251170"
      ],
      "product_description": "Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: \n\n(1) TNG4002-IND. \n(2) TNG-4007-6pk.",
      "code_info": "(1) Model Number: TNG4002-IND; UDI-DI: (1) 00850061601001; Lot numbers: 2510900, 2512938, and 2601944.\n\n(2) Model Number: TNG-4007-6pk; UDI-DI: 00850061601001; Lot numbers: 2510900, 2512938, and 2601944",
      "firm_fei_number": "3041659934",
      "recalling_firm": "TANGENT ENDOSCOPY, LLC",
      "address_1": "2140 S Dupont Hwy",
      "city": "Camden",
      "state": "DE",
      "postal_code": "19934-1249",
      "additional_info_contact": "Daniel Amendola\n707-480-2297",
      "reason_for_recall": "Affected devices exhibited fractures at the distal shaft tip without complete detachment.",
      "root_cause_description": "Process control",
      "action": "On March 23, 2026, URGENT: MEDICAL DEVICE RECALL letters were sent to customers. \nActions to be taken:\nTangent requests that you discontinue use of and return all products from the lot number\nreferenced above. We will ship you new devices and will notify you on ship date.\nOur records indicate that you have purchased one or more of products from these lots.\nPlease acknowledge the email with a confirmation including the devices on hand.\nTo find the lot number, please check the label on the package which clearly states this\ninformation.\n\nInstructions to return inventory:\nPlease ship devices via Fedex overnight delivery, using Account 902012001. Devices must be shipped to the following address:\nTAG3 Engineering - Attention Scott Arp\n1161 Sawgrass Corporate Parkway\nSunrise, FL 33323, USA\n4932-9431-8931 2\nIf you have any questions, please contact Shanita Shafeek at (305) 409-4946 or email\nShanita@avire-med.com",
      "product_quantity": "53 units",
      "distribution_pattern": "US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.",
      "openfda": {
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          "K953286",
          "K231105",
          "K901010",
          "K904799",
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          "K944473",
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          "K912120",
          "K222261",
          "K200483",
          "K231497",
          "K933906",
          "K951191",
          "K924228",
          "K181439",
          "K920224",
          "K051886",
          "K081456",
          "K911480",
          "K771367",
          "K942112",
          "K971977",
          "K251338",
          "K113120",
          "K080586",
          "K221784",
          "K060269",
          "K972926",
          "K233752",
          "K253139"
        ],
        "registration_number": [
          "1418479",
          "3008386005",
          "1828132",
          "9610595",
          "3003790304",
          "3015807001",
          "3041659934",
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          "2024311",
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          "3011050570",
          "1221826",
          "3028058843",
          "9610877"
        ],
        "fei_number": [
          "1418479",
          "3008386005",
          "1828132",
          "3003790304",
          "3002618605",
          "3015807001",
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          "3002808001",
          "3002808268",
          "3011050570",
          "1221826",
          "3001451463",
          "3028058843"
        ],
        "device_name": "Choledochoscope And Accessories, Flexible/Rigid",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2"
      }
    }
  ]
}