{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "190341",
      "product_res_number": "Z-0413-2022",
      "event_date_initiated": "2021-11-09",
      "event_date_created": "2021-12-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2025-09-29",
      "res_event_number": "89029",
      "product_code": "FHW",
      "product_description": "Torosa Saline-Filled Testicular Prosthesis (Size Small)",
      "code_info": "SKU# 5206102400; Catalo # (450-1325); Lot 7685283",
      "firm_fei_number": "2125050",
      "recalling_firm": "Coloplast Manufacturing US, LLC",
      "address_1": "1601 W River Rd",
      "city": "Minneapolis",
      "state": "MN",
      "postal_code": "55411-3431",
      "additional_info_contact": "Coloplast Customer Service\n800-788-0293",
      "reason_for_recall": "Product is mislabeled for size.",
      "root_cause_description": "Process control",
      "action": "A customer letter was issued to affected consignees dated 11/09/2021.  Consignees are asked to move all inventory to quarantine and returned all impacted product within 10 days of letter receipt.  If the product was further distributed, the consignee is directed to notify downstream customers of the recall.\n\nAn Acknowledgement and Receipt Form should be completed indicating the quantity that will be returned.  This should be completed even if there is no inventory.",
      "product_quantity": "19 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the country of Canada.",
      "openfda": {
        "pma_number": [
          "N970012",
          "P000006"
        ],
        "registration_number": [
          "2124215",
          "2183744",
          "2246552",
          "1423662",
          "3005099803",
          "2125050",
          "3002907620"
        ],
        "fei_number": [
          "2124215",
          "3000215273",
          "2183744",
          "2246552",
          "3005099803",
          "2125050",
          "3002907620"
        ],
        "device_name": "Device, Impotence, Mechanical/Hydraulic",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.3350",
        "device_class": "3"
      }
    }
  ]
}