{
  "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": "Reading",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87499",
      "recalling_firm": "Arrow International Inc",
      "address_1": "2400 Bernville Rd",
      "address_2": "N/A",
      "postal_code": "19605-9607",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-1374-2021",
      "product_description": "Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US)  Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended for bone biopsy of the vertebral body and bone lesions.",
      "product_quantity": "3,756 units (US);  249 units (OUS) Expanded 810 units: 774 US and 36 OUS",
      "reason_for_recall": "Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Use of a defective device is likely to require immediate repeat biopsy, leading to a prolonged procedure",
      "recall_initiation_date": "20210308",
      "center_classification_date": "20210407",
      "report_date": "20210414",
      "code_info": "Lot Numbers US:  39647326  39647327  39647328  40422734  40422735    Lot Number:  40808740 (EU)    EXPANDED RECALL: 5/4/21  Lot Numbers:  38347967  40422740"
    }
  ]
}