{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Port Huron",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97605",
      "recalling_firm": "BioPro, Inc.",
      "address_1": "2929 Lapeer Rd",
      "address_2": "",
      "postal_code": "48060-2558",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "US Domestic distribution to Texas and Michigan.",
      "recall_number": "Z-0150-2026",
      "product_description": "BioPro Bipolar Head    Product ID/Description  18130\tBIPOLAR HEAD 38MM  18131\tBIPOLAR HEAD 39MM  18132\tBIPOLAR HEAD 40MM  18133\tBIPOLAR HEAD 41MM  18134\tBIPOLAR HEAD 42MM  18135\tBIPOLAR HEAD 43MM  18136\tBIPOLAR HEAD 44MM  18137\tBIPOLAR HEAD 45MM  18138\tBIPOLAR HEAD 46MM  18139\tBIPOLAR HEAD 47MM  18140\tBIPOLAR HEAD 48MM  18141\tBIPOLAR HEAD 49MM  18142\tBIPOLAR HEAD 50MM  18143\tBIPOLAR HEAD 51MM  18144\tBIPOLAR HEAD 52MM  18145\tBIPOLAR HEAD 53MM  18146\tBIPOLAR HEAD 54MM  18147\tBIPOLAR HEAD 55MM  18148\tBIPOLAR HEAD 56MM  18149\tBIPOLAR HEAD 57MM  18150\tBIPOLAR HEAD 58MM  18151\tBIPOLAR HEAD 59MM  18152\tBIPOLAR HEAD 60MM",
      "product_quantity": "147 total",
      "reason_for_recall": "Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.",
      "recall_initiation_date": "20250909",
      "center_classification_date": "20251014",
      "report_date": "20251022",
      "code_info": "Product ID/UDI-DI  18130 M20918130 18131 M20918131 18132 M20918132 18133 M20918133 18134 M20918134 18135 M20918135 18136 M20918136 18137 M20918137 18138 M20918138 18139 M20918139 18140 M20918140 18141 M20918141 18142 M20918142 18143 M20918143 18144 M20918144 18145 M20918145 18146 M20918146 18147 M20918147 18148 M20918148 18149 M20918149 18150 M20918150 18151 M20918151 18152 M20918152  All lots, all serial numbers",
      "more_code_info": ""
    }
  ]
}