{
  "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": "Terminated",
      "city": "Mentor",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86906",
      "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": "Worldwide distribution - US Nationwide distribution including in the states of CA, DE, CO, VA, FL, WA, TX, OH, PA, MA, IA, CT and the countries of United Kingdom, Saudi Arabia, Portugal, Denmark,  Ireland, United Arab Emirates, South Korea, Australia, Greece, Ashmore & Cartier Islands, Belgium, Canada, China, Germany, Japan, Norway, Poland, Qatar, Romania, Sweden, Thailand.",
      "recall_number": "Z-0830-2021",
      "product_description": "Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during transportation between point of use and cleaning as an initial step of reprocessing.",
      "product_quantity": "23,445 units, Domestic 5,727 units, Foreign 17,718 units",
      "reason_for_recall": "STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens.  The presence of this bacteria can cause the color of the detergent to darken over time.  There is an improbable risk to users of the product from exposure to this bacteria, and no risk to patients.",
      "recall_initiation_date": "20201119",
      "center_classification_date": "20210111",
      "termination_date": "20231025",
      "report_date": "20210120",
      "code_info": "Model# M20350  Lot# 1811273,1811277,1906484,1908593,1909635,1910651,  1911658,2001730,2004770    Model# M20358  Lot# 1903408,1906508,1907556,1909644,2001718,2004772    Model# M20359  Lot# 1811278,1906499,1910649,1911680,1911691,1912708, 2001719,2004768    Model# M20400  Lot# 1901340,1901349,1902374,1904448,1904464,1905505,  1906529,1907571,1908595,1909624,1910653,1912700,  2001717,2004766,2004774,2006797"
    }
  ]
}