{
  "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": "2026-04-01",
    "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": "89931",
      "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": "Visit",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium,  Bulgaria, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, IRELAND, Israel, Italy, Kuwait, Netherlands,  Norway, Oman, Poland, Portugal, Qatar, Saudi Arabia, Slovakia, South Africa, Spain,  Sweden, Switzerland, Taiwan, Unit. Arab Emir.",
      "recall_number": "Z-1082-2022",
      "product_description": "EXALT Model D Single-Use Duodenoscope (Box 2)    UPN: M0054242CE1  Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT\" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.",
      "product_quantity": "OUS: 538 units",
      "reason_for_recall": "Updated Instructions for Use (IFU) for EXALT Model D  Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.",
      "recall_initiation_date": "20220303",
      "center_classification_date": "20220513",
      "report_date": "20220525",
      "code_info": "All lots  GTIN: 08714729995753",
      "more_code_info": ""
    }
  ]
}