{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Winter Park",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86173",
      "recalling_firm": "Genicon, Inc.",
      "address_1": "6869 Stapoint Ct Ste 112",
      "address_2": "N/A",
      "postal_code": "32792-6603",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "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.",
      "recall_number": "Z-0094-2021",
      "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",
      "product_quantity": "10808 units",
      "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).",
      "recall_initiation_date": "20200825",
      "center_classification_date": "20201009",
      "report_date": "20201021",
      "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"
    }
  ]
}