{
  "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": "Terminated",
      "city": "Plymouth",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85486",
      "recalling_firm": "Uromedica Inc.",
      "address_1": "1840 Berkshire Ln N",
      "address_2": "N/A",
      "postal_code": "55441-3723",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide distribution to the following states: CA, GA, FL, MI, and VA.",
      "recall_number": "Z-1808-2020",
      "product_description": "ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced.",
      "product_quantity": "11 tool sets",
      "reason_for_recall": "Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when passes through the sheaths.",
      "recall_initiation_date": "20190410",
      "center_classification_date": "20200428",
      "termination_date": "20200518",
      "report_date": "20200506",
      "code_info": "Model 750041, Lot # UM00650"
    }
  ]
}