{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "178159",
      "product_res_number": "Z-0803-2020",
      "event_date_initiated": "2019-11-27",
      "event_date_posted": "2020-01-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-04-27",
      "res_event_number": "84367",
      "product_code": "OGH",
      "product_description": "BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(10)180900072\n\nThe 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.",
      "code_info": "Part Number/Lot Number  040-333U 170900328 I OGH 040-333U 180800461 I OGH 040-333U 180900072 I OGH 040-333U 180900104 I OGH 040-333U 181000107 I OGH 040-333U 181100013 I OGH 040-333U 181100097 I OGH 040-333U 181200024 I OGH",
      "firm_fei_number": "3006363476",
      "recalling_firm": "Flexicare Medical Ltd.",
      "address_1": "Cynon Valley Business Park, Mountain Ash Cynon Valley Business Park Mountain Ash Rhondda Cynon",
      "city": "Taff",
      "country": "United Kingdom",
      "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.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On 11/27/2019, the firm \"Flexicare\" sent a \"Urgent: medical Device Recall\" letter via USPS Priority mail. The letter informed consignees of the recall. In addition to informing consignees of the recall the letter asked consignees to take the following actions:\n\nComplete the acknowledgment and receipt form and return this form to Flexicare Inc. On receipt of the form you will be contacted by a representative of Flexicare Inc. to make all necessary further arrangements.  The form asked the following of the consignee:\n\n-Acknowledge that you have read and understand the recall instructions provided\n- If you have experienced any adverse events associated with the recalled products.\n- Check your stock and quarantined inventory\n- Send completed response forms marked for the attention of Product Manager Anesthesia to email Ian.ross@flexicare.com or by fax to 949-450-9992\n- Identify and notify your customers that were shipped product from the affected lot numbers\n\nIf you have any questions, please call Product Manager Anesthesia, at 949-450-9999 ext. 102 or email at Ian.Ross@flexicare.com.",
      "product_quantity": "1,024,890 devices",
      "distribution_pattern": "US: Nationwide\nOUS: Australia, Canada, China,  Czech Republic, Denmark, Finland, Ireland, Italy, Kuwait, Lebanon, Netherlands, Panama, Romania, Russia, South Korea, UAE, UK",
      "openfda": {
        "registration_number": [
          "3009888344",
          "3012843412",
          "3003418325",
          "9610691",
          "1061124",
          "2029015",
          "1030451",
          "3004111573",
          "3020460367",
          "9616088",
          "1047429",
          "3035642068",
          "1423537",
          "3007329020",
          "3003431869",
          "1643817"
        ],
        "fei_number": [
          "1000160458",
          "3009888344",
          "3012843412",
          "3003418325",
          "1030451",
          "3002902735",
          "3004111573",
          "3020460367",
          "1047429",
          "3035642068",
          "1000512168",
          "3001236905",
          "3003431869",
          "3007329020",
          "3002806359",
          "1643817"
        ],
        "device_name": "Laryngoscope Kit",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5540",
        "device_class": "1"
      }
    }
  ]
}