{
  "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": "2026-04-01",
    "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": "85734",
      "recalling_firm": "KCI USA, INC.",
      "address_1": "12930 W Interstate 10",
      "address_2": "",
      "postal_code": "78249-2248",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution including in the states of AZ, FL, IL, OH, MD, ND, NV, OK, SC, TN, TX, UT, VA, WA and Puerto Rico. The country of Australia, Austria, Canada, China, France, Germany,  Japan, Hong Kong, India, Indonesia, Malaysia, New Zealand, Philippines, South Korea,  Sri Lanka, Switzerland, Taiwan, Thailand, United Kingdom and Vietnam.",
      "recall_number": "Z-2542-2020",
      "product_description": "ACTIV.A.C Therapy System; Model Numbers; US:  340000\tACTIV.A.C., NORTH AMERICAN  UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home care settings. When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.",
      "product_quantity": "5,823 units",
      "reason_for_recall": "The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy.",
      "recall_initiation_date": "20200608",
      "center_classification_date": "20200709",
      "termination_date": "20230207",
      "report_date": "20200715",
      "code_info": "Products produced from 2007 to 2020 (with software versions up to 3.11)    All serial numbers affected for the following model numbers:    US:  340000 ACTIV.A.C., NORTH AMERICAN  RTMGSM01/US ACTIVAC - RTM, NORTH AMERICAN  Outside:  340001 ACTIV.A.C., UNITED KINGDOM   340003 ACTIV.A.C., AUSTRALIAN   340004 ACTIV.A.C., SPANISH   340005 ACTIV.A.C., GERMAN   340006 ACTIV.A.C., FRENCH   340007 ACTIV.A.C., ITALIAN   340008 ACTIV.A.C., DUTCH   340009 ACTIV.A.C., DANISH   340010 ACTIV.A.C., SWEDISH   340012 ACTIV.A.C., JAPAN  340013 ACTIV.A.C., CANADIAN   340015 ACTIV.A.C., TURKEY   340123 ACTIV.A.C., INDIA   340356 ACTIV.A.C., BRAZIL  415311 ACTIV.A.C., CZECH  415312 ACTIV.A.C., HUNGARIAN  415313 ACTIV.A.C., SLOVAKIAN  415314 ACTIV.A.C., CROATIAN  415315 ACTIV.A.C., POLAND  415316 ACTIV.A.C., SLOVENIA  415317 ACTIV.A.C., SOUTH AFRICA  416008 ACTIV.A.C., INDONESIA  416162 ACTIV.A.C., CHINA  416564 ACTIV.A.C., PHILIPPINES  416599 ACTIV.A.C., EUROPEAN UNION",
      "more_code_info": ""
    }
  ]
}