{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Greenville",
      "state": "SC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69619",
      "recalling_firm": "Soma Access Systems LLC",
      "address_1": "109 Laurens Rd Ste 4c",
      "address_2": "N/A",
      "postal_code": "29607-1860",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CT, FL, GA, IN, KY, LA, MA, MI, MO, NC, NJ, NY OH, OR, PA, SC, TN, TX, VA, and WA and the countries of Belgium, Hong Kong, India, Japan, Panama and Singapore.",
      "recall_number": "Z-0215-2015",
      "product_description": "AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for EU, 5/case labeled for EU).    Sterile Procedure Kit for use AxoTrack enabled Ultrasound Transducer for magnetic needle tracking.",
      "product_quantity": "3530 units",
      "reason_for_recall": "There is a possibility the sterile packaging may fail before the expiration date specified on the package.",
      "recall_initiation_date": "20140324",
      "center_classification_date": "20141114",
      "termination_date": "20150806",
      "report_date": "20141126",
      "code_info": "Product Ref#70956, Lot #62191-000, Expiration Date: 2/28/2014,   Lot #62193-000, Expiration Date: 2/28/2014, Lot #62360-000, Expiration Date: 2/28/2014, Lot #62922-000, Expiration Date: 4/30/2014, Lot #63191-000 and Expiration Date: 10/31/2014 (24/case labeled for US); Product Ref#70957, Lot # 62188-000, Expiration Date: 2/28/2014, Lot # 62435-000, Expiration Date: 2/28/2014, Lot # 62489-000 Expiration Date: 3/31/2014 and Lot # 63191-000, Expiration Date: 10/31/2014 (5/case labeled for US); Product Ref#71489, Lot # 63191-000, Expiration Date: 10/31/2014 (24/case labeled for EU) and Product Ref#71489, Lot # 62489-000, Expiration Date: 3/31/2014, Lot # 62529-000, Expiration Date: 3/31/2014 and Lot # 63191-000 Expiration Date: 10/31/2014 (5/case labeled for EU)."
    }
  ]
}