{
  "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,
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  "results": [
    {
      "status": "Terminated",
      "city": "Rhondda Cynon Taff",
      "state": "",
      "country": "United Kingdom",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84367",
      "recalling_firm": "Flexicare Medical Ltd.",
      "address_1": "Cynon Valley Business Park, Mountain Ash",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "US: Nationwide  OUS: Australia, Canada, China,  Czech Republic, Denmark, Finland, Ireland, Italy, Kuwait, Lebanon, Netherlands, Panama, Romania, Russia, South Korea, UAE, UK",
      "recall_number": "Z-0801-2020",
      "product_description": "BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF 040-713U, Sterile EO, Qty 10, (01)15055788723001     The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.",
      "product_quantity": "1,024,890 devices",
      "reason_for_recall": "The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device.  If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts.",
      "recall_initiation_date": "20191127",
      "center_classification_date": "20200113",
      "termination_date": "20210427",
      "report_date": "20200122",
      "code_info": "Part Number/Lot Number    040-713U 180700030 I CCW  040-713U 180900099 I CCW  040-713U 180901353 I CCW  040-713U 181000110 I CCW  040-713U 181000113 I CCW  040-713U 181100001 I CCW  040-713U 181100002 I CCW  040-713U 181200005 I CCW",
      "more_code_info": ""
    }
  ]
}