{
  "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": "Colorado Springs",
      "state": "CO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93373",
      "recalling_firm": "Spectranetics Corporation",
      "address_1": "9965 Federal Dr",
      "address_2": "N/A",
      "postal_code": "80921-3822",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S Nationwide - Worldwide Distribution:  US Distribution: AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, and WA  Foreign Distribution: Germany, Italy, Poland and Spain",
      "recall_number": "Z-0509-2024",
      "product_description": "Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159    Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006    Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.4 RX REF 414-159    Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.7 OTW REF 417-152    The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of  infrainguinal stenoses and occlusions in humans.",
      "product_quantity": "1,239 catheters",
      "reason_for_recall": "Incorrect product labeling.  Exterior product box label does not match internal pouch label.",
      "recall_initiation_date": "20231115",
      "center_classification_date": "20231208",
      "report_date": "20231220",
      "code_info": "Model Number: 420-159 UDI code: 01)00813132024734(17)250614(10)FAZ23F06A Lot Number: FBH23F02A  Model Number: 420-006 UDI code: (01)00813132024758(17)250622(10)FBA23F09A Lot Number: FBA23F09A  Model Number: 414-159 UDI code: (01)00813132024727(17)250621(10)FBF23F05B Lot Number: FBF23F05B  Model Number: 417-152 UDI code: (01)00813132024765(17)250623(10)FBH23F02A Lot Number: FAZ23F06A"
    }
  ]
}