{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Irving",
      "address_1": "3041 Skyway Cir N",
      "reason_for_recall": "The device labeling is stamped with 330cc and the device is actually 380cc device.",
      "address_2": "",
      "product_quantity": "34 units",
      "code_info": "Part Number (PN) 351-3380SZ    Lot Number 6830722",
      "center_classification_date": "20140904",
      "distribution_pattern": "U.S Nationwide Distribution in the states of Michigan, Maryland, Texas, New Jersey, Indiana, Nevada, Florida, California, New York, Tennessee, Pennsylvania, and Colorado.",
      "state": "TX",
      "product_description": "EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer   REF 351-3380SZ 380 cc LOT 6830722.      Product Usage:  This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted.",
      "report_date": "20140910",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Mentor Texas, LP.",
      "recall_number": "Z-2591-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "69022",
      "termination_date": "20150406",
      "more_code_info": "",
      "recall_initiation_date": "20140702",
      "postal_code": "75038-3500",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}