{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "St Martin D Heres",
      "state": "",
      "country": "France",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84460",
      "recalling_firm": "Imactis",
      "address_1": "20 Rue Du Tour De L Eau",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: WI & IL",
      "recall_number": "Z-0838-2020",
      "product_description": "Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482, Adhesif Film Ref. 38.20.15 CE 0459, EN Navigation Kit. Compatible with linear instruments of diameter ranging from 0.5 mm to 3.0 mm (25G to 11G), Sterile, Rx Only,",
      "product_quantity": "122 kits",
      "reason_for_recall": "The firm has become aware that the sensor cover, a component of the single-use navigation kit  may contain microbial contamination. A source of microbial contamination has been identified in a raw product used to manufacture the tip of the cover.This could result in direct exposure of the intra-cardiovascular, intra-lymphatic or neurological system to a level of endotoxin sufficient to produce a pyrogenic response.",
      "recall_initiation_date": "20190801",
      "center_classification_date": "20200122",
      "report_date": "20200129",
      "code_info": "Lot # 18120001/Exp. 2020-04-01 and Lot # 19040001/Exp. 2021-01-22",
      "more_code_info": ""
    }
  ]
}