{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Marlborough",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93281",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "100 Boston Scientific Way",
      "address_2": "N/A",
      "postal_code": "01752-1234",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "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.",
      "recall_number": "Z-0397-2024",
      "product_description": "EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0.",
      "product_quantity": "US: 5,709 devices & OUS: 180 devices",
      "reason_for_recall": "Poor image quality due to fluid ingress in the lens.",
      "recall_initiation_date": "20230927",
      "center_classification_date": "20231121",
      "report_date": "20231129",
      "code_info": "UDI-DI (GTIN): 08714729993605, Outer box UPN# M00542421, Inner box UPN # M00542420, Lot / Batch # 31118200, 31537337, 31118202, 31538040, 31129470, 31544823, 31145980, 31544825, 31150536, 31590918, 31150537, 31591865, 31150538, 31607291, 31175587, 31619981, 31193809, 31627631, 31193810, 31636279, 31232040, 31643793, 31239963, 31676406, 31248263, 31683921, 31251918, 31692257, 31269307, 31697145, 31275008, 31706116, 31283026, 31710191, 31305347, 31718478, 31322088, 31726052, 31334176, 31729292,31338402, 31734350, 31347461, 31738755, 31348990, 31738756, 31357937, 31754162, 31360721, 31762358, 31366683, 31764634, 31373783, 31767053, 31409362, 31774421, 31416272, 31783669, 31424741, 31826665, 31429697, 31828975, 31430274, 31846317, 31440192, 31858409, 31447120, 31874720, 31454624, 31915555, 31458181, 31939608, 31462880, 32033589, 31472232, 32047032, 31474875, 32082692, 31537336.       UDI-DI (GTIN): 08714729995753, Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0, Lot /Batch # 31118201, 31331654 31129503, 31817723, 31265893.",
      "more_code_info": ""
    }
  ]
}