{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Valencia",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92181",
      "recalling_firm": "Boston Scientific Neuromodulation Corporation",
      "address_1": "25155 Rye Canyon Loop",
      "address_2": "N/A",
      "postal_code": "91355-5004",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution: IN, NY, IL, PA, FL, SC, TX, MA, VA, AL, WI, OK, MO, MI, OH, WV, NC, UT, NH, CA, NJ, TN, NV, AZ, NE, IA, CT, ME, LA, KY, MS, MD, DC, GA, CO, KS, ID, MN, AR, HI, NM, WA, SD, OR, DE, WY, AK, and ND",
      "recall_number": "Z-1972-2023",
      "product_description": "Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual",
      "product_quantity": "21,533",
      "reason_for_recall": "Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver teeth/tips) within the implant location; and if metal fragments are not removed and remain in situ, MRI scans are NOT advised due to potential risk of patient injury.",
      "recall_initiation_date": "20230512",
      "center_classification_date": "20230615",
      "report_date": "20230621",
      "code_info": "Driver UDI-DI: 00884662000574, UPN: 102-9800, All Lots.  Superion Indirect Decompression System IFU (92479815-02), Superion IDS Kit IFU (92479820-02), Surgical Technique Manual (92479821-02)"
    }
  ]
}