{
  "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": "San Clemente",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83869",
      "recalling_firm": "Pacific Medical Group Inc.",
      "address_1": "212 Avenida Fabricante",
      "address_2": "N/A",
      "postal_code": "92672-7538",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.: IN, AZ, IL, HI, AK, AR, CA, FL, GA, IA, ID, LA, MA, NC, NE, NM, NY, OK, PA, TN, TX, UT, VA, WA, WV, NV, KY, CO, ME, ND, OH, SC, WI, AL, OR, DC, DE, MD, MI, MN, MO, MT, MS, NJ, NH.    O.U.S. (Foreign): CA, CO, FR, GB, IT, MX, UAE",
      "recall_number": "Z-0980-2020",
      "product_description": "Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260",
      "product_quantity": "628",
      "reason_for_recall": "Fetal transducers distributed in advance of receiving 510(k) and international clearances. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and interruption of monitoring  due to device failure that could lead to delay in detecting maternal or fetal distress.",
      "recall_initiation_date": "20190919",
      "center_classification_date": "20200204",
      "report_date": "20200212",
      "code_info": "All serial numbers distributed between 02/06/16 - 04/30/19."
    }
  ]
}