{
  "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": "Caledonia",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88476",
      "recalling_firm": "Aspen Surgical Products, Inc.",
      "address_1": "6945 Southbelt Dr SE",
      "address_2": "N/A",
      "postal_code": "49316-7664",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US nationwide distribution. No foreign distribution.",
      "recall_number": "Z-2390-2021",
      "product_description": "Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400",
      "product_quantity": "124",
      "reason_for_recall": "Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.",
      "recall_initiation_date": "20210723",
      "center_classification_date": "20210830",
      "termination_date": "20220726",
      "report_date": "20210908",
      "code_info": "All lots manufactured between July 9, 2019 to July 9, 2021"
    }
  ]
}