{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "41815",
      "product_res_number": "Z-0001-06",
      "event_date_initiated": "2005-09-13",
      "event_date_posted": "2005-10-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-12-30",
      "res_event_number": "33407",
      "product_code": "FXY",
      "k_numbers": [
        "K910515"
      ],
      "product_description": "Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems, Wheeling, IL 60090",
      "code_info": "Part #10450, Catalog # SA-500/US, lot number 16963",
      "firm_fei_number": "3011270181",
      "recalling_firm": "VIASYS Med Systems",
      "address_1": "100 Chaddick Dr",
      "city": "Wheeling",
      "state": "IL",
      "postal_code": "60090-6006",
      "additional_info_contact": "Ms. Stephanie Wasielewski\n800-323-6305",
      "reason_for_recall": "The packaging may be compromised such that sterility of the hoods cannot be guaranteed.",
      "root_cause_description": "Other",
      "action": "VIASYS telephoned the direct accounts and sent out follow-up faxes on 9/13/05. The accounts were informed of the potential for compromised packages seals and questionable sterility, and were instructed to check their inventory for the affected catalog numbers and lots numbers. The accounts were instructed to hold any affected product and contact VIASYS at 1-800-323-6305 to arrange for the return goods authorization. The dealers were requested to sub-recall the affected product from their customers.",
      "product_quantity": "481 cases",
      "distribution_pattern": "Nationwide and internationally to Japan, Chile and Switzerland",
      "openfda": {
        "k_number": [
          "K880431",
          "K770261",
          "K904969",
          "K902677",
          "K222214",
          "K904276",
          "K140588",
          "K903533",
          "K760855",
          "K761070",
          "K200493",
          "K770257",
          "K760865"
        ],
        "registration_number": [
          "2032098",
          "3030733800",
          "3015967359",
          "3012494290",
          "3010432890",
          "1055236",
          "1043214",
          "3031572397",
          "3008837339",
          "3002806603",
          "1054241",
          "3017300722",
          "1721686",
          "1526350",
          "3016678045",
          "3014479313",
          "3007309299",
          "3020163307",
          "3012497308",
          "3013557562",
          "3014213264",
          "3002807090",
          "3036773433",
          "3033536319",
          "3008328679"
        ],
        "fei_number": [
          "3030733800",
          "3015967359",
          "3012494290",
          "3010432890",
          "1043214",
          "3031572397",
          "1000112968",
          "3008837339",
          "3002806603",
          "3017300722",
          "1721686",
          "1526350",
          "3016678045",
          "3014479313",
          "3007309299",
          "3020163307",
          "3012497308",
          "3013557562",
          "3014213264",
          "1000112877",
          "3036773433",
          "3006003617",
          "3033536319",
          "3008328679",
          "3003058448"
        ],
        "device_name": "Hood, Surgical",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4040",
        "device_class": "2"
      }
    }
  ]
}