{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89170",
      "recalling_firm": "Acclarent, Inc.",
      "address_1": "31 Technology Dr  Suite 200",
      "address_2": "N/A",
      "postal_code": "92618-2346",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: AZ, MI, IA, LA, IL, VA, SC, NY, IN, OR, SD, TX, PA, NE, FL, CT, MN, NV, CA, NJ, UT, AL, MA, WI, TN, WV, OH, NC, KY, HI¿, OK, GA, CO, MO, WY, MS, NH, HI, MD, ID",
      "recall_number": "Z-0415-2022",
      "product_description": "TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z",
      "product_quantity": "1543",
      "reason_for_recall": "Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy error, this could lead to an intraprocedural delay, a potential for reversible tissue damage or damage to the carotid artery, CSF leak, or damage to optic nerve.",
      "recall_initiation_date": "20211112",
      "center_classification_date": "20211222",
      "report_date": "20211229",
      "code_info": "0-Degree Lots: 1903120, 1903250, 1904060, 1904180, 1904240, 1905030, 1905070, 1906260, 1907120, 1907170, 1907220, 1907240, 1907260, 2003040, 2009110, 2011240, 2102080, 2103090, 2104260, 2105040, 2105260, 2106100, 2107070. 70-Degree Lots: 1903137, 1903257, 1904067, 1905017, 1905037, 1905077, 1906067, 1906267, 1907127, 1908137, 1908157, 2003127. 90-Degree: 1903139, 1903259, 1904069, 1905019, 1905139, 1906079, 1908269, 1909279, 1909309, 1910299, 2003029, 2004029"
    }
  ]
}