{
  "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-0148-2026",
      "product_description": "BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads    Part ID/Description:  18593\tHEAD FEMORAL 22MM -3  18594\tHEAD FEMORAL 22MM +0  19003\tHEAD FEMORAL 28MM-6  19004\tHEAD FEMORAL 28MM-3  19005\tHEAD FEMORAL 28MM+0  19006\tHEAD FEMORAL 28MM+3  19007\tHEAD FEMORAL 28MM+6  19008\tHEAD FEMORAL 28MM+9  19053\tHEAD FEMORAL 36MM -3  19054\tHEAD FEMORAL 36MM +0  19055\tHEAD FEMORAL 36MM +3  19056\tHEAD FEMORAL 36MM +6  19057\tHEAD FEMORAL 36MM +9  19130\tHEAD FEMORAL 32MM-6  19131\tHEAD FEMORAL 32MM-3  19132\tHEAD FEMORAL 32MM+0  19133\tHEAD FEMORAL 32MM +3  19134\tHEAD FEMORAL 32MM+6  19135\tHEAD FEMORAL 32MM +9",
      "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": "Part ID/ UDI-DI:  18593 M20918593 18594 M20918594 19003 M20919003 19004 M20919004 19005 M20919005 19006 M20919006 19007 M20919007 19008 M20919008 19053 M20919053 19054 M20919054 19055 M20919055 19056 M20919056 19057 M20919057 19130 M20919130 19131 M20919131 19132 M20919132 19133 M20919133 19134 M20919134 19135 M20919135  All lots and serial numbers affected",
      "more_code_info": ""
    }
  ]
}