{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Largo",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "68313",
      "recalling_firm": "BioDerm, Inc.",
      "address_1": "12320 73rd Ct",
      "address_2": "N/A",
      "postal_code": "33773-3011",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, NH, NJ, NY, PA, TX, and WI, and the countries of Canada and Netherlands.",
      "recall_number": "Z-1743-2014",
      "product_description": "BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes).     The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.",
      "product_quantity": "26,040 units.",
      "reason_for_recall": "On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry.  This component (wipes) were initially manufacturer by Smith & Nephew and recalled due to a potential bacterial contamination.",
      "recall_initiation_date": "20110531",
      "center_classification_date": "20140610",
      "termination_date": "20140620",
      "report_date": "20140618",
      "code_info": "Lot Codes: Range from U24401 through U29801;    Model Numbers: 23046, 23036, 21046, 21036. 21026 and 21006."
    }
  ]
}