{
  "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": "",
      "country": "Sweden",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "94197",
      "recalling_firm": "Elekta Instrument AB",
      "address_1": "Kungstensgatan 18",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "US and Australia, Austria, Belgium, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland",
      "recall_number": "Z-1397-2024",
      "product_description": "Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System.  Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube.",
      "product_quantity": "601 needles",
      "reason_for_recall": "Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles. The sterility of the biopsy needles has not been affected. This issue has been reported from one site.",
      "recall_initiation_date": "20240315",
      "center_classification_date": "20240416",
      "report_date": "20240424",
      "code_info": "Lot number 837838839 appears on the labels for REF 911933, REF 911761, and REF 912465.  UDI numbers:  REF 911933 - (01)0 7340048 30034 6, (17)250401 (10) 837838839 (240) 911933; REF 911761 - (01)0 7340048 30800 7, (17)250401 (10) 837838839 (240) 911761; REF 912465 - (01)0 7340048 30801 4, (17)250401 (10) 837838839 (240) 912465.",
      "more_code_info": ""
    }
  ]
}