{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 299
    }
  },
  "results": [
    {
      "cfres_id": "149424",
      "product_res_number": "Z-0002-2017",
      "event_date_initiated": "2016-08-25",
      "event_date_created": "2016-10-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-12-01",
      "res_event_number": "75127",
      "product_code": "MAV",
      "k_numbers": [
        "K122321"
      ],
      "product_description": "Merit Inflation Syringe Kit. Catalog Number KOS-02857",
      "code_info": "Lot Numbers: H959038, H970334, H984351.",
      "firm_fei_number": "1721504",
      "recalling_firm": "Merit Medical Systems, Inc.",
      "address_1": "1600 W Merit Pkwy",
      "city": "South Jordan",
      "state": "UT",
      "postal_code": "84095-2416",
      "additional_info_contact": "Cory Marsh\n801-316-3690",
      "reason_for_recall": "Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.",
      "root_cause_description": "Labeling design",
      "action": "Merit Medical Inc. notified all affected customers on August 25, 2016, via verbal and written notification to return the affected units. \n\nThe returned units will be re-labeled.\n\nFor further questions, please call (801) 316-3690.",
      "product_quantity": "1,297 total units",
      "distribution_pattern": "One consignee located in CA. No Canadian, other foreign or VA/govt/military consignees.",
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        "device_name": "Syringe, Balloon Inflation",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1650",
        "device_class": "2"
      }
    }
  ]
}