{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "217885",
      "product_res_number": "Z-1362-2026",
      "event_date_initiated": "2025-12-18",
      "event_date_posted": "2026-02-13",
      "recall_status": "Open, Classified",
      "res_event_number": "98202",
      "product_code": "KNS",
      "k_numbers": [
        "K243568"
      ],
      "product_description": "Teslatome Bipolar Sphincterotomes\nREF: TESLA-B2535-260\nModel Number: G60784\nUDI-DI code: 00827002607842\n\nREF: TESLA-B2535-450\nModel Number: G60785\nUDI-DI code: 00827002607859\n\nThese devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.",
      "code_info": "RPN: TESLA-B2535-260\nModel Number: G60784\nUDI-DI code: 00827002607842\nWork Order Number / RPN\nW4954835 /  TESLA-B2535-260\nW4954836 / TESLA-B2535-260\nW4957208 / TESLA-B2535-260\nW4958992 / TESLA-B2535-260\nW4960895 / TESLA-B2535-260\nW4960896 / TESLA-B2535-260\nW4961670 / TESLA-B2535-260\nW4965708 / TESLA-B2535-260\nW4966040 / TESLA-B2535-260\nW4966803 / TESLA-B2535-260\nW4967866 / TESLA-B2535-260\nW4968515 / TESLA-B2535-260\nW4968867 / TESLA-B2535-260\nW4969292 / TESLA-B2535-260\nW4969674 / TESLA-B2535-260\nW4969687 / TESLA-B2535-260\nW4970315 / TESLA-B2535-260\nW4970662 / TESLA-B2535-260\nW4971561 / TESLA-B2535-260\nW4972693 / TESLA-B2535-260\nW4973085 / TESLA-B2535-260\nW4974435 / TESLA-B2535-260\nW4974588 / TESLA-B2535-260\nW4975407 / TESLA-B2535-260\nW4975688 / TESLA-B2535-260\nW4977514 / TESLA-B2535-260\nW4977824 / TESLA-B2535-260\nW4979182 / TESLA-B2535-260\nW4979183 / TESLA-B2535-260\nW4979665 / TESLA-B2535-260\nW4982425 / TESLA-B2535-260\nW4982436 / TESLA-B2535-260\n\nREF: TESLA-B2535-450\nModel Number: G60785\nUDI-DI code: 00827002607859\nWork Order Number / RPN:\nW4962311 / TESLA-B2535-450\nW4966039 / TESLA-B2535-450\nW4968222 / TESLA-B2535-450\nW4969306 / TESLA-B2535-450\nW4970322 / TESLA-B2535-450\nW4971499 / TESLA-B2535-450\nW4975687 / TESLA-B2535-450\nW4977254 / TESLA-B2535-450\nW4982013 / TESLA-B2535-450",
      "firm_fei_number": "1037905",
      "recalling_firm": "Wilson-Cook Medical Inc.",
      "address_1": "4900 Bethania Station Rd",
      "city": "Winston Salem",
      "state": "NC",
      "postal_code": "27105-1203",
      "additional_info_contact": "Cook Medical\n800-457-4500",
      "reason_for_recall": "Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 12/18/2025, the firm priority mailed an \"URGENT: MEDICAL DEVICE RECALL\" Letter to customers informing them that the firm is removing Teslatome Bipolar Sphincterotomes from the market because they are nonconforming. \n\nCustomers are instructed to:\n1. Examine inventory immediately to determine if you have affected devices. Immediately cease use of the affected devices and quarantine all affected devices.\n2. Return the affected devices to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a credit.\n3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected devices on hand, you must still complete the Acknowledgement and Receipt Form and return via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com).\n4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred.\n5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com.\n\nFor questions, contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235",
      "product_quantity": "153",
      "distribution_pattern": "U.S. Distribution to states of: CA, CO, IN, and NC.",
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}