{
  "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": "Ongoing",
      "city": "Portage",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88199",
      "recalling_firm": "Stryker Medical Division of Stryker Corporation",
      "address_1": "3800 E Centre Ave",
      "address_2": "N/A",
      "postal_code": "49002-5826",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.",
      "recall_number": "Z-2212-2021",
      "product_description": "ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009",
      "product_quantity": "3 units",
      "reason_for_recall": "Medical devices intended for use in a healthcare facility were  distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the  correct use environment, but home users may not be aware of or fully understand these instructions  intended for healthcare professionals",
      "recall_initiation_date": "20210512",
      "center_classification_date": "20210806",
      "report_date": "20210818",
      "code_info": "Serial Numbers:   20170928500311838  UDI:  07613327277852  07613327277937"
    }
  ]
}