{
  "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": "Brisbane",
      "address_1": "3240 Bayshore Blvd",
      "reason_for_recall": "Cutera received two adverse events associated with the edge of the electrode, when it was pressed against neck skin over the thyroid cartilage and due to the absence of adequate underlying conductive tissue, increased skin heating occurred. Both patients developed linear welts and blisters consistent with partial thickness thermal burns to the skin.",
      "address_2": "",
      "product_quantity": "451",
      "code_info": "Serial Numbers:  TS10140  TS10052  TS10107  TS10161  TS10086  TS10136  TS10083  TS10045  TS10032  TS10075  TS10100  TS10070  TS10129  TS10049  TS10040  TS10055  TS10160  TS10046  TS10117  TS10137  TS10141  TS10080  TS10097  TS10037  TS10131  TS10138  TS10119  TS10088  TS10074  TS10114  TS10145  TS10066  TS10106  TS10155  TS10056  TS10094  TS10139  TS10022  TS10128  TS10112  TS10068  TS10124  TS10078  TS10134  TS10079  TS10002  TS10109  TS10156  TS10135  TS10110  TS10008  TS10115  TS10093  TS10146  TS10050  TS10017  TS10054  TS10029  TS10104  TS10048  TS10090  TS10062  TS10024  TS10158  TS10071  TS10035  TS10059  TS10153  TS10025  TS10087  TS10130  TS10133  TS10101  TS10103  TS10125  TS10018  TS10089  TS10023  TS10147  TS10033  TS10015  TS10014  TS10039  TS10085",
      "center_classification_date": "20131209",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to Canada",
      "state": "CA",
      "product_description": "Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA    The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite. The truSculpt infrared (optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.",
      "report_date": "20131218",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Cutera, Inc.",
      "recall_number": "Z-0427-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "66674",
      "termination_date": "20131209",
      "more_code_info": "",
      "recall_initiation_date": "20131016",
      "postal_code": "94005-1021",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}