{
  "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": "Minneapolis",
      "address_1": "1601 W River Rd",
      "reason_for_recall": "Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box and Patient Labels indicate a size 9 mm, instead of 9.5 mm.  The device size is printed directly on the individual prosthesis tray during the packaging process and states the correct size, 9.5 mm.",
      "address_2": "",
      "product_quantity": "11 (6 USA, 5 OUS)",
      "code_info": "4336612,   4364589 , 4413811,  4413812,  4336613, 4413810.",
      "center_classification_date": "20150427",
      "distribution_pattern": "Worldwide - US Nationwide Distribution in the states of FL, NY, TX and the country of FRANCE",
      "state": "MN",
      "product_description": "Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250.    Product Usage:  The Coloplast Genesis Penile prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction.",
      "report_date": "20150506",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Coloplast Manufacturing US, LLC",
      "recall_number": "Z-1538-2015",
      "initial_firm_notification": "Visit",
      "product_type": "Devices",
      "event_id": "70960",
      "termination_date": "20150911",
      "more_code_info": "",
      "recall_initiation_date": "20150409",
      "postal_code": "55411-3431",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}