{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "151050",
      "product_res_number": "Z-0749-2017",
      "event_date_initiated": "2016-11-14",
      "event_date_posted": "2016-12-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-09-13",
      "res_event_number": "75682",
      "product_code": "OUP",
      "k_numbers": [
        "K161885"
      ],
      "product_description": "Cellfina Prep Pack, Part No. CP1",
      "code_info": "all",
      "firm_fei_number": "1012187",
      "recalling_firm": "Ulthera Inc",
      "address_1": "1840 S Stapley Dr Ste 200 1840 S Stapley Dr",
      "address_2": "Ste 200",
      "city": "Mesa",
      "state": "AZ",
      "postal_code": "85204-6681",
      "additional_info_contact": "Ulthera Customer Service\n480-619-4069",
      "reason_for_recall": "It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup.",
      "root_cause_description": "Other",
      "action": "Ulthera sent an Urgent Medical Device Recall letter dated November 15, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.\n\nIt was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup.  Customers are informed of the actions to be taken.  Customers with any technical or logistical questions are instructed to contact technical support at Ulthera, Inc. at (480) 619-4069.  \n\nThe letter informs the customers with questions related to their Cellfina business are instructed to  contact Merz North America at 888-751-7546 or at mymerzsolutions@merz.com.",
      "product_quantity": "6562 units",
      "distribution_pattern": "Worldwide Distribution - US Distribution and to the countries of :Europe (Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, UK)",
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          "K161885",
          "DEN110004",
          "K153677",
          "K232153",
          "K212399",
          "K192185",
          "K150505",
          "K221336",
          "K134010"
        ],
        "registration_number": [
          "1721676",
          "3009905888",
          "3043012240",
          "3023808190",
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          "3043149902",
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          "3013840437",
          "3043011436",
          "3043657394",
          "3010273872",
          "3015452693"
        ],
        "device_name": "Powered Surgical Instrument For Improvement In The Appearance Of Cellulite",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4790",
        "device_class": "2"
      }
    }
  ]
}