{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "cfres_id": "215061",
      "product_res_number": "Z-2324-2025",
      "event_date_initiated": "2025-06-04",
      "event_date_posted": "2025-08-14",
      "recall_status": "Open, Classified",
      "res_event_number": "97282",
      "product_code": "FFX",
      "k_numbers": [
        "K190208"
      ],
      "product_description": "Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10",
      "code_info": "UDI-DI: 00816734022863, Lot: 24752",
      "firm_fei_number": "2023374",
      "recalling_firm": "Diversatek Healthcare",
      "address_1": "9150 Commerce Center Cir Ste 500 9150 Commerce Center Cir",
      "address_2": "Ste 500",
      "city": "Highlands Ranch",
      "state": "CO",
      "postal_code": "80129-1563",
      "additional_info_contact": "Laura L. Boll\n303-470-7020",
      "reason_for_recall": "Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct expiration date.",
      "root_cause_description": "Error in labeling",
      "action": "On 6/4/2025, field safety notices were emailed to GI Lab / Endoscopy Unit Managers who were asked to do the following:\n\nCheck your inventory for devices with the part and lot numbers listed below.\n2. Discard any affected product.\n3. Complete and return the attached MEDICAL DEVICE RECALL RETURN RESPONSE form via email to clahr@diversatek.com\n\nIf you have questions about this issue, please contact your Sales Representative or the firm at 1-800-558-6408",
      "product_quantity": "8",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.",
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        "device_name": "System, Gastrointestinal Motility (Electrical)",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1725",
        "device_class": "2",
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