{
  "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": "Danvers",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92521",
      "recalling_firm": "Abiomed, Inc.",
      "address_1": "24 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 Nationwide distribution in the states  of MN, NJ, TN.",
      "recall_number": "Z-2128-2023",
      "product_description": "Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457",
      "product_quantity": "37 units",
      "reason_for_recall": "There was one complaint that the sidearm of the device detached during explant of a pump.  When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally introduced during manufacturing at the joint between the sidearm and the hub may cause the joint to detach.",
      "recall_initiation_date": "20230526",
      "center_classification_date": "20230711",
      "report_date": "20230719",
      "code_info": "UDI-DI: 00813502013252; Lot Numbers: 1727033, 1725590",
      "more_code_info": ""
    }
  ]
}