{
  "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": "Center Valley",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92893",
      "recalling_firm": "Olympus Corporation of the Americas",
      "address_1": "3500 Corporate Pkwy",
      "address_2": "N/A",
      "postal_code": "18034-8229",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.",
      "recall_number": "Z-2663-2023",
      "product_description": "Veran : Percutaneous Always on Track  Models:  INS-5040\tAlways-On vTrack Universal Tracker, LG 7-12ga\t\t\t\t\t  INS-5039\tAlways-On vTrack Universal Tracker, SM/CL, 12-18ga\t\t\t\t\t  INS-5036\t\"22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar  point\"\t\t\t\t\t  INS-5034\t17 UTW Lg 123mm Always-On Tip Tracked Biopsy Needle, Chiba point\t\t\t\t\t00815686020354  INS-5032\t\"19 UTW 150mm Always-On Tip Tracked Biopsy Needle, Chiba point\"\t\t\t\t  INS-5029\t\"19 UTW 105 mm Always-On Tip Tracked biopsy needle, Chiba oint\"\t\t\t\t\t  INS-5028\t19 UTW 155 mm Always-On Tip Tracked biopsy needle, Chiba point\t\t\t\t\t  INS-5024\t\"17ga 150mm Always-On Tip Tracked Biopsy Needle, Chiba point\"\t\t\t\t\t  INS-5023\t17ga 100mm Always-On Tip Tracked Biopsy Needle, Chiba point\t\t\t\t\t  INS-5017\t17ga x 155mm Tip Tracked Bx Needle\t\t\t\t\t  INS-5016\t17ga x 155mm Tip Tracked Bx Needle",
      "product_quantity": "522 units",
      "reason_for_recall": "Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments)  manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment",
      "recall_initiation_date": "20230810",
      "center_classification_date": "20230929",
      "report_date": "20231011",
      "code_info": "Model-UDI: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga  00815686020705; INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga     00815686020699; INS-5036 \"22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar point\"   00815686020361; INS-5034 17 UTW Lg 123mm Always-On Tip Tracked Biopsy Needle, Chiba point     00815686020354; INS-5032 \"19 UTW 150mm Always-On Tip Tracked Biopsy Needle, Chiba point\"     00815686020330; INS-5029 \"19 UTW 105 mm Always-On Tip Tracked biopsy needle, Chiba point\"     00815686020309; INS-5028 19 UTW 155 mm Always-On Tip Tracked biopsy needle, Chiba point     00815686020293; INS-5024 \"17ga 150mm Always-On Tip Tracked Biopsy Needle, Chiba point\"     00815686020255; INS-5023 17ga 100mm Always-On Tip Tracked Biopsy Needle, Chiba point     00815686020248; INS-5017 17ga x 155mm Tip Tracked Bx Needle   00815686020224; INS-5016 17ga x 155mm Tip Tracked Bx Needle   00815686020217;   All serial numbers and all lot numbers"
    }
  ]
}