{
  "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": "North Billerica",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93331",
      "recalling_firm": "Breas Medical, Inc.",
      "address_1": "16 Esquire Rd",
      "address_2": "",
      "postal_code": "01862-2527",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide Foreign: Canada",
      "recall_number": "Z-0405-2024",
      "product_description": "with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc  Kits: 006093, 006653,  an accessory to  ventilator device, Vivo 45LS.    intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.",
      "product_quantity": "215 units",
      "reason_for_recall": "Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of ventilation",
      "recall_initiation_date": "20231013",
      "center_classification_date": "20231127",
      "report_date": "20231206",
      "code_info": "UDI-DI: 05030267120505  NIV Angled Mouthpiece with Notch 22M/15F;              07321820060931  MPV Kit 006093;              07321820066537  MPV Kit 006653   MPV mouthpiece Lot Numbers: 32304444, 32305269 and 32306017",
      "more_code_info": ""
    }
  ]
}