{
  "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": "Pleasanton",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81576",
      "recalling_firm": "Neotract  Inc",
      "address_1": "4473 Willow Rd Ste 100",
      "address_2": "N/A",
      "postal_code": "94588-8570",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV,",
      "recall_number": "Z-0598-2019",
      "product_description": "UroLift System  REF Catalog Number: UL400-4  Tray Contents: UroLift System with Handle Release Tool  STERILE R  CE 0050  Manufactured By: neotract",
      "product_quantity": "8,804",
      "reason_for_recall": "Upon implant deployment, the Capsular Tab may not be delivered as the needle is retracted.  In this failure mode, the needle is deployed into the prostate and retracted, leaving no implant behind.  Failure to deliver a capsular tab may result in a delay in completing a treatment or an inability to complete a treatment for the patient.  Use of a recalled device may lead to increased frequency of exiting known risks associated with the product, including bleeding and tissue trauma associated with delivering the needle.",
      "recall_initiation_date": "20180706",
      "center_classification_date": "20181212",
      "termination_date": "20201202",
      "report_date": "20181219",
      "code_info": "Model: AN00141 (US) and  AN00142 (OUS);  Catalog No.: UL400-4;    Lots: P37940, P37943, P37953, P37956, P37965, P37971, P37985, P37988, P37995, P38001, P38013, P38020, P38124, P38132"
    }
  ]
}