{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 17
    }
  },
  "results": [
    {
      "cfres_id": "198898",
      "product_res_number": "Z-1359-2023",
      "event_date_initiated": "2023-03-01",
      "event_date_posted": "2023-04-12",
      "recall_status": "Open, Classified",
      "res_event_number": "91800",
      "product_code": "FHW",
      "pma_numbers": [
        "P000006"
      ],
      "product_description": "Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis",
      "code_info": "UDI/DI 05708932533966, Lot Numbers:  8849559, 8849560, 8849623, 8887867, 8849624, 8497256, 8904186",
      "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\n800-258-3476",
      "reason_for_recall": "A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.",
      "root_cause_description": "Process change control",
      "action": "The firm issued an URGENT MEDICAL DEVICE VOLUNTARY RECALL notice on 03/01/2023 by UPS next day air.  The notice explained the issue and the hazard to health.  The notice requests the removal and return of the affected product.  Distributors are instructed to notify their customers.\n\nFor further questions, please contact the Coloplast Customer Service team directly at (800) 258-3476, or by email urology@coloplast.com.",
      "product_quantity": "18 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.",
      "openfda": {
        "pma_number": [
          "N970012",
          "P000006"
        ],
        "registration_number": [
          "3002907620",
          "2124215",
          "1423662",
          "2183744",
          "2246552",
          "3005099803",
          "2125050"
        ],
        "fei_number": [
          "3002907620",
          "2124215",
          "2183744",
          "2246552",
          "3000215273",
          "3005099803",
          "2125050"
        ],
        "device_name": "Device, Impotence, Mechanical/Hydraulic",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.3350",
        "device_class": "3"
      }
    }
  ]
}