{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "194578",
      "product_res_number": "Z-1420-2022",
      "event_date_initiated": "2022-06-03",
      "event_date_created": "2022-07-20",
      "recall_status": "Open, Classified",
      "res_event_number": "90488",
      "product_code": "CBI",
      "k_numbers": [
        "K203749"
      ],
      "product_description": "Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, \n412371000, \n412391000, \n412411000",
      "code_info": "Catalog No: 412351000 UDI-DI: 5707480145706   1 each  5707480145713   5 pc/pack  Catalog No. 412371000 UDI-DI: 5707480145737   1 each 5707480145744   5 pc/pack  Catalog No. 412391000 UDI-DI: 5707480145768   1 each 5707480145775   5 pc/pack  Catalog No. 412411000 UDI-DI: 5707480145799   1 each 5707480145805   5 pc/pack   All lots",
      "firm_fei_number": "1121788",
      "recalling_firm": "Ambu Inc.",
      "address_1": "6230 Old Dobbin Ln Ste 250 6230 Old Dobbin Ln",
      "address_2": "Ste 250",
      "city": "Columbia",
      "state": "MD",
      "postal_code": "21045-5955",
      "additional_info_contact": "Tammy Feyerherm\n800-262-8462",
      "reason_for_recall": "Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secure airway and will require re-intubation of patient.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On June 3, 2022, the firm notified customers of the recall through email. Customers were instructed to discard their affected product and report the amount back to the firm. The firm will provide replacement product or credit to affected customers.",
      "product_quantity": "12,921",
      "distribution_pattern": "Domestic distribution nationwide. \nForeign distribution to Austria, Belgium, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norge, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, UK\nCanada, Australia, New Zealand, Israel\n.",
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        "registration_number": [
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        "device_name": "Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5740",
        "device_class": "2"
      }
    }
  ]
}