{ "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": 2 } }, "results": [ { "cfres_id": "181839", "product_res_number": "Z-2949-2020", "event_date_initiated": "2020-06-10", "event_date_created": "2020-09-10", "recall_status": "Open, Classified", "res_event_number": "85822", "product_code": "EOQ", "k_numbers": [ "K182188" ], "product_description": "Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.", "code_info": "All lots.", "firm_fei_number": "3001675293", "recalling_firm": "Intuitive Surgical, Inc.", "address_1": "1266 Kifer Rd Bldg 101 1266 Kifer Rd", "address_2": "Bldg 101", "city": "Sunnyvale", "state": "CA", "postal_code": "94086-5304", "additional_info_contact": "408-523-2100", "reason_for_recall": "One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System.", "root_cause_description": "Device Design", "action": "The firm notified their consignees regarding the \"Urgent Medical Device Recall\" notification via Fedex, and issued on 06/10/2020. The actions to be taken by the Customer/User are as follows:\nLocate the affected product at the site and return to the recalling firm via the standard RMA process.\nAs part of the standard field action process, please take the following actions:\n1. Inform necessary hospital personnel about this issue.\n2. Inform necessary personnel when corrective action has been completed.\n3. Complete the Acknowledgement Form and return to the recalling firm as instructed on the form.\n4. Please retain a copy of letter and Acknowledgement Form for reference.\n\nActions to be taken by the recalling firm:\n1. A firm representative will make contact to support in replacing the affected product.\n2. The firm will promptly overnight replacement product (PN 490118) after Customer Service is contacted by phone and receives the number of affected Catheter Reprocessing Covers (PN 490114-02) at the hospital.\nIf further information is needed or support concerning the Medical Device Recall, contact your Sales Representative or contact Customer Service at the number listed below:\nCustomer Support: 1-866-225-2071, Option 3 (7 AM to 5 PM EST) or Customerservice@intusurg.com.", "product_quantity": "67 units", "distribution_pattern": "U.S.: California, Colorado, Florida, Illinois, Massachusetts, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, and Virginia.\nNo foreign consignees.", "openfda": { "k_number": [ "K811181", "K172955", "K163537", "K242324", "K983878", "K962367", "K962533", "K130845", "K950965", "K220606", "K960880", "K023376", "K943700", "K760171", "K260382", "K811218", "K242070", "K202370", "K221302", "K183085", "K922937", "K914181", "K770500", "K191828", 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