{
  "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,
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  "results": [
    {
      "cfres_id": "182949",
      "product_res_number": "Z-0094-2021",
      "event_date_initiated": "2020-08-25",
      "event_date_created": "2020-10-09",
      "recall_status": "Open, Classified",
      "res_event_number": "86173",
      "product_code": "N/A",
      "product_description": "Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site",
      "code_info": "Model # 720-005-000 (BPSI SET WITH NO PROBE); Lot # I9214-C  Model # 720-005-001 (BPSI SET 8 VENT PROBE); Lot Numbers:  I8881-D I8873-D I9057-D I9058-D I9209-D I9213-D I9227-D I9235-D I9236-D I9237-D I9278-D I9280-D I9282-D I9283-D I9299-D I9309-D I9322-D I9324-D I9356-D I9358-D I9360-D I9361-D I9362-D I9363-D I9364-D I9365-D",
      "firm_fei_number": "3002590791",
      "recalling_firm": "Genicon, Inc.",
      "address_1": "6869 Stapoint Ct Ste 112 6869 Stapoint Ct",
      "address_2": "Ste 112",
      "city": "Winter Park",
      "state": "FL",
      "postal_code": "32792-6603",
      "additional_info_contact": "Thomas Calcaterra\n407-657-4851",
      "reason_for_recall": "The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the hand-piece did not receive proper premarket clearance from US FDA and lacks a 510(k).",
      "root_cause_description": "Device Design",
      "action": "Genicon issued an updated urgent medical device recall notification on August 29,2020 and initial urgent medical device recall notification was sent on August 24, 2020.  The notification states the following action to be taken:\n\nTo Distributors:\n\nPlease encourage your customers to complete and return the enclosed response form as soon as possible and return the form by e-mail to customerservice@geniconendo.com.\n\nIn addition, if you or your customers have any of the affected devices, contact Genicon Customer Service , to coordinate the return of the product associated with this action at no additional cost.  \n\nGenicon Customer Service Contact Information\n\nGenicon Customer Service Manager \n+1-407-657-4851, extension #800, \nMonday through Thursday 9AM-4PM USA Eastern Time Zone.\nE-mail: customerservice@geniconendo.com.\n\n\nTo Users:\n\n(1)Please confirm whether any of the affected product remains in your inventory by completing the attached Medical Device Recall Response Form and e-mailing it to customerservice@geniconendo.com.\n\n(2) Should you find affected product in your inventory, do not use them. \n\n(3)Please return affected product to Genicon, Inc. (see below contact details).\n\nGenicon Customer Service Manager (contact information below) to coordinate the return at no additional cost.\n\nNAME, Genicon Customer Service Manager \n+1-407-657-4851, extension #800, \nMonday through Thursday 9AM-4PM USA Eastern Time Zone.\nE-mail: customerservice@geniconendo.com.",
      "product_quantity": "10808 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, IA, IL, IN, MA, MI, MO, NC, OH, TN, VA, WA, WI and the countries of ECUADOR, HONG KONG, QATAR, SAUDI ARABIA, UAE (Dubai),  JORDAN,  KUWAIT, SOUTH AFRICA.",
      "openfda": {}
    }
  ]
}