{
  "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": 4
    }
  },
  "results": [
    {
      "cfres_id": "219337",
      "product_res_number": "Z-1938-2026",
      "event_date_initiated": "2026-03-18",
      "event_date_posted": "2026-04-23",
      "recall_status": "Open, Classified",
      "res_event_number": "98649",
      "product_code": "KNQ",
      "product_description": "Diversatek Healthcare Viper 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08",
      "code_info": "UDI/DI 00816734021699, Lot Numbers:  005983",
      "firm_fei_number": "2183446",
      "recalling_firm": "Diversatek Healthcare",
      "address_1": "102 E Keefe Ave",
      "city": "Milwaukee",
      "state": "WI",
      "postal_code": "53212-1535",
      "additional_info_contact": "Laura L. Boll\n414-265-7620",
      "reason_for_recall": "The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.",
      "root_cause_description": "Labeling Change Control",
      "action": "Diversatek Healthcare issued an URGENT:  MEDICAL DEVICE RECALL notice to its consignees on 3/18/2026 via USPS.  The notice explained the problem, risk to health, and requested the consignee discard any affected product.  Complete and return the attached MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form and provide Signature Confirming Customer Receipt to Laura Boll, VP Regulatory Affairs & Quality at lboll@diversatek.com or 414-755-4806 to receive a replacement order.  \nFor questions about this issue, please contact Laura Boll, Vice President - Regulatory Affairs & Quality, at 414-755-4806 or lboll@diversatek.com.",
      "product_quantity": "15 units",
      "distribution_pattern": "US:  MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium",
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        "device_name": "Dilator, Esophageal",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5365",
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