{
  "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": "Terminated",
      "city": "Center Valley",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86367",
      "recalling_firm": "Olympus Corporation of the Americas",
      "address_1": "3500 Corporate Pkwy",
      "address_2": "PO Box 610",
      "postal_code": "18034-0610",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution in states of: AK, AZ, CA, FL, GA, IL, LA, MA, ME, MI, MN, MS, NC, NM,  NJ, NY, OR, SC, TN, WA, and WI; and International to: Japan.",
      "recall_number": "Z-0119-2021",
      "product_description": "Olympus CHF-CB30S Choledoscope     Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile duct, cystic duct, and hepatic duct).",
      "product_quantity": "193 devices distributed in the U.S. 548 devices distributed globally.",
      "reason_for_recall": "The CHF-CB30S Device did not have a 510(k) clearance. Additionally, the device has been associated with breakage of the insertion section and protrusion of metal parts, as well as breakage and displacement of the rubber on the bending section during surgical procedures.",
      "recall_initiation_date": "20200831",
      "center_classification_date": "20201016",
      "termination_date": "20221206",
      "report_date": "20201028",
      "code_info": "All lot codes.."
    }
  ]
}