{
  "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": "Ongoing",
      "city": "Marlborough",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89862",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "100 Boston Scientific Way",
      "address_2": "",
      "postal_code": "01752-1234",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - US Nationwide distribution.",
      "recall_number": "Z-1003-2022",
      "product_description": "SpaceOAR Vue System, UPN SV-1010 and SV-2101.  Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.",
      "product_quantity": "23,368 units",
      "reason_for_recall": "Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue.",
      "recall_initiation_date": "20220224",
      "center_classification_date": "20220425",
      "report_date": "20220504",
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      "more_code_info": ""
    }
  ]
}