{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "158580",
      "product_res_number": "Z-0416-2018",
      "event_date_initiated": "2017-07-26",
      "event_date_created": "2018-01-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-04-06",
      "res_event_number": "78058",
      "product_code": "OUW",
      "product_description": "7x10\" Small Utility Positioner with Cover",
      "code_info": "Recorder Code 1400227",
      "firm_fei_number": "1629080",
      "recalling_firm": "Molnlycke Health Care, Inc",
      "address_1": "5550 Peachtree Pkwy Ste 500 5550 Peachtree Pkwy",
      "address_2": "Ste 500",
      "city": "Norcross",
      "state": "GA",
      "postal_code": "30092-2555",
      "additional_info_contact": "470-250-7952",
      "reason_for_recall": "Products may not meet specifications due to possible presence of metal shavings.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Customers were notified by letter via overnight mail on approximately 07/26/2017.  Instructions include identify and quarantine affected product in inventory, contact Molnlycke to arrange return of affected product, and complete and return the Acknowledgement Form.",
      "product_quantity": "960 units total",
      "distribution_pattern": "Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.",
      "openfda": {
        "k_number": [
          "K172962"
        ],
        "device_name": "Infant Positioner, Rx, Use In Highly Monitored Setting",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5680",
        "device_class": "1"
      }
    }
  ]
}