{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "192099",
      "product_res_number": "Z-0820-2022",
      "event_date_initiated": "2022-02-14",
      "event_date_created": "2022-03-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2026-07-02",
      "res_event_number": "89644",
      "product_code": "IOQ",
      "product_description": "Compella Bariatric Bed System",
      "code_info": "All lots/serial numbers\n\nUDI information:\nCompella Bariatric Bed - 00887761000902",
      "firm_fei_number": "1417572",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "1 Baxter Pkwy",
      "city": "Deerfield",
      "state": "IL",
      "postal_code": "60015-4625",
      "reason_for_recall": "Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.",
      "root_cause_description": "Labeling design",
      "action": "Customer notification letters were mailed beginning 02/21/2022.\n\nA localized customer letter will be mailed (with signature service) to all first-level consignees by Sedgwick. The letter will inform the customer of the issue, reason for Field Action and provide risk mitigations. The customer will be instructed to sign acknowledgement form to confirm receipt and return to a dedicated email address. \n\nDistributors will be asked to forward to their end users. Distributors will be provided with instructions on communication with their end users.\n\nAll consignees will be required to return a signed acknowledgment form and confirm that they read and understand the issue.\n\nDistributors will be asked to forward to their end users. Distributors will be provided instruction on communication with their end users.",
      "product_quantity": "5186 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Cameroon, Canada, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Jamaica, Jordan, Kuwait, Mexico, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkmenistan, UAE, and UK.",
      "openfda": {
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          "K143414",
          "K881843",
          "K880486",
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          "K964873",
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        "registration_number": [
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        ],
        "device_name": "Bed, Flotation Therapy, Powered",
        "medical_specialty_description": "Physical Medicine",
        "regulation_number": "890.5170",
        "device_class": "2"
      }
    }
  ]
}