{
  "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": [
    {
      "country": "United States",
      "city": "Minnetonka",
      "address_1": "10700 Bren Rd W",
      "reason_for_recall": "American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary Control System,  Control Pump &  Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria.",
      "address_2": "",
      "product_quantity": "77",
      "code_info": "Model #       Lot #    72400024 771029003  72400024 794405011  72400024 744211005  72400024 794405007  72400024 744211008  72400024 771029001  72400024 794405006  72400024 771029005  72400024 744211009  72400024 771029016  72400023 741419006  72400024 794405001  72400024 794405002  72400024 794405004  72400024 794405005  72400024 794405015  72400024 794405016  72400024 744211001  72400024 744211004  72400024 800345007  72400024 800345014  72400024 771029012  72400024 794405009  72400024 794405012  72400024 794405013  72400024 794405014  72400023 741419004  72400023 741419005  72400023 741419007  72400023 741419009  72400023 741419010  72400024 744211002  72400024 744211003  72400024 744211006  72400024 744211007  72400024 744211010  72400024 744211011  72400024 771029002  72400024 771029004  72400024 771029006  72400024 771029007  72400024 771029008  72400024 771029009  72400024 771029010  72400024 771029011  72400025 803589003  72400024 771029014  72400024 771029015  72400025 803589005  72400024 794405003  72400024 771029013  72400024 794405008  72400024 800345008  72400024 794405010  72400024 800345001  72400024 800345003  72400024 800345004  72400024 800345005  72400024 800345006  72400024 800345009  72400024 800345010  72400024 800345012  72400024 800345015  72400024 800345002",
      "center_classification_date": "20130510",
      "distribution_pattern": "Worldwide Distribution -- Nationwide Distribution including the states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY,NC, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VT, VA, WA and WI., and the countries of  AUSTRIA, AUSTRALIA, CANADA, BELGIUM, SWITZERLAND, CZECH REPUBLIC, GERMANY, DENMARK, ESTONIA, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, IRELAND, ITALY, LEBANON, NETHERLANDS, NORWAY, SWEDEN, TURKEY, ARGENTINA, BRAZIL, IVORY COST, COLOMBIA, ECUADOR, INDIA, JAPAN, MEXICO, NEW ZEALAND, PANAMA and VENEZUELA.",
      "state": "MN",
      "product_description": "AMS 800¿ Urinary Control System.     The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800¿ Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck.",
      "report_date": "20130522",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "American Medical Systems, Inc.",
      "recall_number": "Z-1280-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "64875",
      "termination_date": "20140424",
      "more_code_info": "",
      "recall_initiation_date": "20130301",
      "postal_code": "55343-9679",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}