{
  "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,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "215875",
      "product_res_number": "Z-0016-2026",
      "event_date_initiated": "2025-08-29",
      "event_date_posted": "2025-10-01",
      "recall_status": "Open, Classified",
      "res_event_number": "97535",
      "product_code": "MEC",
      "product_description": "Getinge 88-Series Washer- Disinfector. Model Number: 88-5.",
      "code_info": "Model Number: 88-5. UDI-DI Numbers: 07340153700109, 07340153700116. Software Version: GD 14080 Rev A.  All Lot Numbers with electrical heating.",
      "firm_fei_number": "3000231474",
      "recalling_firm": "Getinge Disinfection Ab",
      "address_1": "Ljungadalsgatan 11 11 ljungadalsgatan",
      "city": "Vaxjo",
      "country": "Sweden",
      "reason_for_recall": "Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Getinge notified consignees on about 08/29/2025 via letter. Consignees were instructed that Getinge service technicians will be proactively reaching out to ensure affected devices are calibrated appropriately. In the meantime, Getinge has developed a verification procedure to ensure that the circulation pressure in standby mode is correctly calibrated to 0.0 kPa. If the value deviates, recalibration by a qualified technician is required. The verification of the circulation pressure shall be performed by the operator or Getinge technician. If the value deviates from 0.0 kPa out of allowed tolerances (1 kPa), stop using the device immediately and work with your Getinge service technician to arrange recalibration.  Consignees were also instructed to ensure all caregivers and users of the affected product are made aware of the recall and to complete and return the provided response form. \n \n***UPDATE 10/16/2025: Firm notified FDA of an expansion to include additional OUS units and one additional complaint. \n \n***UPDATE 03/02/2026: Firm notified FDA of an expansion to include additional OUS units and one additional complaint.",
      "product_quantity": "902 units",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of Colorado, Massachusetts, New Mexico, New Hampshire and the countries of Algeria, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Austria, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Kenya, Korea, Republic of, Kuwait, Lithuania, Mexico, Netherlands, Norway, New Zealand, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom.",
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        "device_name": "Disinfector, Medical Devices",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.6992",
        "device_class": "2",
        "k_number": [
          "K911120",
          "K081094"
        ]
      }
    }
  ]
}