{
  "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": "Stockholm",
      "state": "N/A",
      "country": "Sweden",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91780",
      "recalling_firm": "Elekta Instrument AB",
      "address_1": "Kungstensgatan 18",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of AZ, CA, CO, FL, GA, ID, IL, KS, MA, MD, MI, MN, MO, MS, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI, and WV.  There was also government distribution.",
      "recall_number": "Z-1309-2023",
      "product_description": "Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments:    (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III;  (2) Part #A2800-15, Backlund Catheter Insertion Needle Kit I;  (3) Part #A2600-01, Backlund Haematoma Evacuator Kit;  (4) Part #A2200-01, Salcman Twist Drill Kit I;  (5) Part #907801, Insertion Cannula Kit;  (6) Part #50398-01, Catheter Inserter Needle 1,5;  (7) Part #307165, Insertion Cannula 190 MM;  (8) Part #60377-02, Twist Drill 3.2 MM;  (9) Part #60377-01, Twist Drill 2.1 MM;  (10) Part #50376-01, Salcman Twist Drill 2.1/3.2;  (11) Part #14001050, Catheter Inserter Needle 2,6; and  (12) Part #1002248, Frame G w Straight/Curved Front.",
      "product_quantity": "70 devices",
      "reason_for_recall": "The incorrect IFU was distributed with the devices.",
      "recall_initiation_date": "20230301",
      "center_classification_date": "20230330",
      "report_date": "20230405",
      "code_info": "UDI-DI:  (1) 07340048301305; (2) 07340048300285; (3) 07340048301220; (4) 07340048301145; (5) 07340048300315; (6) 07340048308618; (7) 07340048308632; (8) 07340048308571; (9) 07340048308564; (10 07340048308601; (11) 07340048308625; and  (12) 07340048306348."
    }
  ]
}