{
  "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": "Center Valley",
      "state": "PA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "96087",
      "recalling_firm": "Olympus Corporation of the Americas",
      "address_1": "3500 Corporate Pkwy",
      "address_2": "",
      "postal_code": "18034-8229",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US nationwide distribution.",
      "recall_number": "Z-1071-2025",
      "product_description": "Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers:    1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-201    2. Single Use Guide Sheath Kit K-202 2.0MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number: K-202    3. Single Use Guide Sheath Kit K-203 2.6MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-203    4.  Single Use Guide Sheath Kit K-204 2.6MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number: K-204.    Used to collect cells or tissue specimens in the respiratory organs.",
      "product_quantity": "454 units",
      "reason_for_recall": "Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.",
      "recall_initiation_date": "20250115",
      "center_classification_date": "20250211",
      "report_date": "20250219",
      "code_info": "1. Model Number: K-201; UDI-DI: 04953170245466; All Lots.   2. Model Number: K-202; UDI-DI: 04953170245480; All Lots  3. Model Number: K-203; UDI-DI: 04953170245503; All Lots  4. Model Number: K-204; UDI-DI: 04953170245527; All Lots",
      "more_code_info": ""
    }
  ]
}