{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Bloomington",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77307",
      "recalling_firm": "Cook Inc.",
      "address_1": "750 N Daniels Way",
      "address_2": "N/A",
      "postal_code": "47404-9120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of:  AK  AL  AZ  CA  CO  FL  GA  HI  IA  ID  IL  IN  KS  KY  LA  MA  MD  ME  MI  MN  MO  MS  MT  NC  NJ  NY  OH  OR  PA  SC  SD  TN  TX  WA  WI    Foreign: Australia, Bolivia, Brazil, Canada, Chile, Columbia, Cyprus, Czech Republic, Germany, Dominican Republic, Greece, Hong Kong, Ireland, Israel, India, Iran, Jordan, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Latvia, Libya, Mexico, Malaysia, New Zealand, Oman, Panama, Peru, Portugal, Serbia, Turkey, Trinidad and Tobago, Taiwan, and Venezuela.  VA/DOD: Yes- see below",
      "recall_number": "Z-2585-2017",
      "product_description": "OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages    Product Usage:  Used with the Odyssey 30\u001d Holmium Laser System for fragmentation of urinary calculi and soft tissue applications including incision/excision, ablation, and coagulation",
      "product_quantity": "10,415",
      "reason_for_recall": "Cook Inc. is initiating a voluntary recall of the OptiLite Multi-Use Holmium Laser Fibers because it has been identified that the reprocessing instructions do not provide sufficiently detailed information for the cleaning, disinfection, and sterilization of these products.",
      "recall_initiation_date": "20170503",
      "center_classification_date": "20170614",
      "termination_date": "20190326",
      "report_date": "20170621",
      "code_info": "OptiLite Multi-Use Holmium Laser Fibers, Catalog Numbers followed by GPN:  HLF-M273-CNV, G48611  HLF-M273-SMA, G48522  HLF-M365-CNV, G48613  HLF-M365-SMA, G48618  HLF-M550-CNV, G48615  HLF-M550-SMA, G48619  HLF-M940-CNV, G48617  HLF-M940-SMA, G48621  HLF-M273-CNV-CAN, G51777  HLF-M273-SMA-CAN, G51785  HLF-M365-CNV-CAN, G51778  HLF-M365-SMA-CAN, G51786  HLF-M550-CNV-CAN, G51779  HLF-M550-SMA-CAN, G51787  HLF-M940-CNV-CAN, G51780  HLF-M940-SMA-CAN, G51788"
    }
  ]
}