{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Mentor",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79100",
      "recalling_firm": "Steris Corporation",
      "address_1": "5960 Heisley Rd",
      "address_2": "N/A",
      "postal_code": "44060-1834",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution",
      "recall_number": "Z-0761-2018",
      "product_description": "Vis-U-All High Temp 3.5\"x9\" Self Seal Pouch 200 pouches per box; 4 boxes per case    Product Usage:  The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.",
      "product_quantity": "139",
      "reason_for_recall": "On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch.",
      "recall_initiation_date": "20170615",
      "center_classification_date": "20180227",
      "termination_date": "20180717",
      "report_date": "20180307",
      "code_info": "Model# 884039  Lot# 161228A and #170228A"
    }
  ]
}