{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Danvers",
      "state": "MA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89328",
      "recalling_firm": "Abiomed, Inc.",
      "address_1": "22 Cherry Hill Dr",
      "address_2": "N/A",
      "postal_code": "01923-2575",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "US distribution to FL, GA, IN, MD, NC, PA, TX.",
      "recall_number": "Z-0550-2022",
      "product_description": "OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass.       OXY-1 System consists of Console, Pump Drive,  E Drive, and Pole Mount. The disposable Pump Lung Unit  PLU  part number 001-0400-100 is sold separately and is not part of this recall.",
      "product_quantity": "42 Units",
      "reason_for_recall": "The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use, which disrupts therapy delivered to a patient on support. Disruption of therapy could lead to prolonged hypoxia.",
      "recall_initiation_date": "20211214",
      "center_classification_date": "20220203",
      "termination_date": "20230228",
      "report_date": "20220209",
      "code_info": "UDI 00860001797909   Software Version Number V-1.3.15.0, V-1.4.6.0 and V.1.4.8.0    Serial Numbers   20200231-04 20200249-01 20200249-05 20200309-02 20200339-01 20200339-03 20200352-01 20200442-01 20200442-02 20200442-05 20210768-01 20210795-02 20210870-01 20210880-01 20210890-01 20210894-01 20210895-01 20210896-01 20210897-01 20210795-04"
    }
  ]
}