{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Brecksville",
      "address_1": "8000 Katherine Blvd",
      "reason_for_recall": "The firm received a complaint of an open pouch which breaches the sterilization validation.",
      "address_2": "",
      "product_quantity": "2,263 Units",
      "code_info": "Part #: TLC5042 & TLC5042-I",
      "center_classification_date": "20160504",
      "distribution_pattern": "Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI.    Product was also shipped to the following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.",
      "state": "OH",
      "product_description": "Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize   Product Usage:  Indicated to aid in tissue retraction during a surgical procedure.",
      "report_date": "20160511",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Applied Medical Technology Inc",
      "recall_number": "Z-1610-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "73318",
      "termination_date": "20161027",
      "more_code_info": "",
      "recall_initiation_date": "20160217",
      "postal_code": "44141-4202",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}