{
  "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 II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "96723",
      "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": "",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.",
      "recall_number": "Z-1922-2025",
      "product_description": "Brand Name: Powered Laser Surgical Instrument  Product Name: Soltive SuperPulsed Laser Fibers - Single Use  Model/Catalog Numbers: TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TLF-FBX940S, TFL-FBX150BS-JA (Japan Only), TFL-FBX550S-JA (Japan Only), TFL-FBX940S-JA (Japan Only), TFL-FBX200BS-JA (Japan Only), TFL-FBX150S-JA  (Japan Only), TFL-FBX200S-JA  (Japan Only), TFL-FBX365S-JA (Japan Only);    Product Description: SOLTIVE Laser Fibers are delivery devices that transmit laser energy from the laser console to the treatment site through the fiber tip. The laser connector secures the device to the laser.",
      "product_quantity": "551,154 units (417859 US, 133710 OUS)",
      "reason_for_recall": "Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.",
      "recall_initiation_date": "20250506",
      "center_classification_date": "20250606",
      "report_date": "20250618",
      "code_info": "Lot Code: All lot numbers for the following products:  TFL-FBX150BS        UDI: 00821925043923; TFL-FBX200BS        UDI: 00821925043985; TFL-FBX150S           UDI: 00821925043886; TFL-FBX200S           UDI: 00821925043947; TFL-FBX365S           UDI: 00821925044005; TFL-FBX550S           UDI: 00821925044043; TFL-FBX940S           UDI: 00821925044081; TFL-FBX150BS-JA (Japan Only); TFL-FBX550S-JA (Japan Only); TFL-FBX940S-JA (Japan Only); TFL-FBX200BS-JA (Japan Only); TFL-FBX150S-JA  (Japan Only); TFL-FBX200S-JA  (Japan Only); TFL-FBX365S-JA (Japan Only);",
      "more_code_info": ""
    }
  ]
}