{
  "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": [
    {
      "status": "Terminated",
      "city": "San Antonio",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "62805",
      "recalling_firm": "KCI USA, Inc.",
      "address_1": "4958 Stout Dr",
      "address_2": "N/A",
      "postal_code": "78219-4334",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution including AL, CA, CO, OK and GA.",
      "recall_number": "Z-0409-2013",
      "product_description": "RotoRest Delta Kinetic Therapy System    INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction",
      "product_quantity": "282 units",
      "reason_for_recall": "The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack.  KCI has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack.  In a few instances, the patient received injuries ranging from Stage III to Stage IV pressure ulcers.",
      "recall_initiation_date": "20120627",
      "center_classification_date": "20121120",
      "termination_date": "20130422",
      "report_date": "20121128",
      "code_info": "Model Number 208030, Serial Numbers: 00157087, 00157091, 00157288, 00157375, 00157405, RRCKOO011, RRHKOO065, RRHKOO074, RRHKOO096, RRHK00109, and RRHKOO117."
    }
  ]
}