{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "66884",
      "product_res_number": "Z-0591-2008",
      "event_date_initiated": "2007-11-13",
      "event_date_posted": "2008-01-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-03-25",
      "res_event_number": "46149",
      "product_code": "NWX",
      "pma_numbers": [
        "P050018"
      ],
      "product_description": "AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA.",
      "code_info": "Lot Number: F07090015",
      "firm_fei_number": "3005462046",
      "recalling_firm": "AngioScore Inc.",
      "address_1": "5055 Brandin Ct",
      "city": "Fremont",
      "state": "CA",
      "postal_code": "94538-3140",
      "additional_info_contact": "510-933-7904",
      "reason_for_recall": "Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton",
      "root_cause_description": "Process control",
      "action": "The firm initiated a field correction and issued Medical Device Field correction letters to its consignees on 11/09/2007, instructing consignees to review their inventory and return any mislabeled product or contact the firm.",
      "product_quantity": "40 units",
      "distribution_pattern": "Nationwide-to 30 medical facilities in NC, SC, OH, IL, NY, PA, NJ, PA, LA, KS, FL, WI, MI, WA, and CA.",
      "openfda": {
        "pma_number": [
          "P230026",
          "P050018",
          "P200041",
          "P950020"
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        "registration_number": [
          "3002807314",
          "9681260",
          "1721676",
          "3000126629",
          "2011171",
          "3015002281",
          "3005462046",
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          "3010273872"
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          "1721676",
          "3000126629",
          "2011171",
          "3015002281",
          "3005462046",
          "1000121056",
          "3003775186",
          "2124215",
          "3002807315",
          "3010273872"
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        "device_name": "Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
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}