{
  "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,
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  },
  "results": [
    {
      "status": "Terminated",
      "city": "Newark",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86138",
      "recalling_firm": "Pharmaceutical Innovations, Inc.",
      "address_1": "897 Frelinghuysen Ave",
      "address_2": "N/A",
      "postal_code": "07114-2122",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution including in the state of Nevada.",
      "recall_number": "Z-2830-2020",
      "product_description": "Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.",
      "product_quantity": "tbd",
      "reason_for_recall": "The firm registered the product as a Class I device, but has since been informed by FDA that the device is not Class I and requires a 510(k) submission.",
      "recall_initiation_date": "20200813",
      "center_classification_date": "20200820",
      "termination_date": "20210916",
      "report_date": "20200826",
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