{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "210762",
      "product_res_number": "Z-0530-2025",
      "event_date_initiated": "2024-10-28",
      "event_date_posted": "2024-11-25",
      "recall_status": "Open, Classified",
      "res_event_number": "95608",
      "product_code": "EZY",
      "pma_numbers": [
        "P000053"
      ],
      "product_description": "AMS Artificial Urinary Sphincter Control Pump",
      "code_info": "UPN Number: 72400098. GTIN Number: 00878953000688. Lot Number: 32487464. Serial Numbers: 1100366307, 1100366316, 1100366309, 1100366317, 1100366310, 1100366319, 1100366311, 1100366320, 1100366312, 1100366321, 1100366313, 1100366323, 1100366314, 1100366324, 1100366315, 1100366325.  \n\nExpiration Date: 09/24/2028",
      "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\n508-683-4000",
      "reason_for_recall": "Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)",
      "root_cause_description": "Error in labeling",
      "action": "Boston Scientific notified their consignees on about 10/28/2024 via letter. Consignees were instructed to immediately discontinue use and segregate the affected products, notify all personnel that need to be aware, notify customers if further distributed, arrange for the return of affected product and complete and return the Reply Verification Tracking Form (RVtF).",
      "product_quantity": "16 units",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, KS, LA, MA, MI, MN, NY, OR, PA, TX, VA, WA and the countries of Argentina, Australia, Austria, Belgium, Chile, China, Costa Rica, Czech Republic, Finland, France, Germany, Ireland, Netherlands, Poland, Puerto Rico, South Korea, Spain, Sweden, Switzerland, and Taiwan.",
      "openfda": {
        "pma_number": [
          "P130018",
          "P000053"
        ],
        "device_name": "Device, Incontinence, Mechanical/Hydraulic",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5280",
        "device_class": "3",
        "registration_number": [
          "1423662",
          "3005099803",
          "2124215",
          "3003477176"
        ],
        "fei_number": [
          "3005099803",
          "2124215",
          "3000215273",
          "3003477176"
        ]
      }
    }
  ]
}