{
  "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": "216083",
      "product_res_number": "Z-0140-2026",
      "event_date_initiated": "2025-09-11",
      "event_date_posted": "2025-10-10",
      "recall_status": "Open, Classified",
      "res_event_number": "97603",
      "product_code": "JCW",
      "product_description": "CX Preconnect with TENACIO Pump without InhibiZone;\nUPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);",
      "code_info": "1.\tUPN: 72404486 (15CM IP); UDI-DI: 00191506021658; Lot numbers: 1100676851, 1100676852;\n2.\tUPN: 72404488 (21CM IP); UDI-DI: 00191506021672; Lot numbers: 1100717673;",
      "firm_fei_number": "3005099803",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "100 Boston Scientific Way",
      "city": "Marlborough",
      "state": "MA",
      "postal_code": "01752-1234",
      "additional_info_contact": "Renee Archie\n508-683-4523",
      "reason_for_recall": "The potential for devices to experience inflation and/or deflation performance issues or difficulties.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On September 11, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: For implanted devices: If the device is working properly, no action is required. Further evaluation is recommended for patients who were implanted with an affected device AND are having difficulty inflating or deflating the device.\n- Check inventory for affected product and return any unused devices. Immediately cease further distribution or use of any unused affected devices. Please pass this notice to any healthcare professional from your organization that needs to be aware and to any organization\nwhere the potentially affected devices have been transferred. Please provide Boston Scientific with details of any affected\ndevices that have been transferred to another organization.",
      "product_quantity": "1 unit",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the country of Canada.",
      "openfda": {
        "pma_number": [
          "N970012"
        ],
        "device_name": "Prosthesis, Penis, Inflatable",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.3350",
        "device_class": "3",
        "registration_number": [
          "3005099803",
          "2124215",
          "3013987875",
          "3013960851"
        ],
        "fei_number": [
          "3005099803",
          "2124215",
          "3013987875",
          "3013960851"
        ]
      }
    }
  ]
}