{
  "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": "2026-03-18",
    "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": "90433",
      "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",
      "recall_number": "Z-1382-2022",
      "product_description": "Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation    Model Number: 230000     ¿\tIf the recalled product is a software, include version number: firmware versions 5.0.5 or earlier",
      "product_quantity": "1,113 units",
      "reason_for_recall": "A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could potentially be Permanent impairment or life threatening if medical intervention is not obtained",
      "recall_initiation_date": "20220602",
      "center_classification_date": "20220713",
      "report_date": "20220720",
      "code_info": "Unique Device Identifier (UDI): UDI 07321822300004.    Serial number ranges in scope are: D******, K******, M01**** to M040124, where asterisk (*) denotes a digit from 0 to 9.",
      "more_code_info": ""
    }
  ]
}