{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "203827",
      "product_res_number": "Z-0396-2024",
      "event_date_initiated": "2023-09-27",
      "event_date_posted": "2023-11-21",
      "recall_status": "Open, Classified",
      "res_event_number": "93281",
      "product_code": "FDT",
      "k_numbers": [
        "K193202"
      ],
      "product_description": "EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.",
      "code_info": "UDI-DI (GTIN): 08714729983514, Outer box UPN# M00542420, Lot / Batch # 31137538, 31537335, 31228699, 31590604, 31257049, 31635405, 31257050, 31683854, 31258726, 31802917, 31329914, 31810037, 31398618, 31991955, 31438355, 32006891,\t31473069, 32146684. \t\n\nUDI-DI (GTIN): 08714729995746, Outer box UPN# M0054242CE0, Lot / Batch # 31199348, 31712358, 31574944.",
      "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": "Rebecca Kinkead Rubio\n763-494-1133",
      "reason_for_recall": "Poor image quality due to fluid ingress in the lens.",
      "root_cause_description": "Process control",
      "action": "Notification of Urgent Medical Device Product Removal was issued via FedEx on Oct 3, 2023. The notice advises customers to immediately discontinue use and segregate affected product, and to complete and return the Reply Verification and Tracking Form (RVTF) even if you do not have any affected product.  Customers are to post the notice near any affected product and notify end users. If further distributed, notify any customers to which product has been further distributed to. Reach out to your local Boston Scientific representative with any questions. The notice is batch / lot specific. Boston Scientific has implemented\ncorrective changes and will make replacement EXALT Model D scopes available as soon as possible.",
      "product_quantity": "US: 586 devices & OUS: 81 devices",
      "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA VT, WA, WI & WV. The countries of Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Great Britain, Italy, New Zealand, Spain, Sweden, Switzerland.",
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        ],
        "registration_number": [
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        ],
        "fei_number": [
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          "3002913962",
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          "3017210488",
          "3003058448"
        ],
        "device_name": "Duodenoscope And Accessories, Flexible/Rigid",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2"
      }
    }
  ]
}