{
  "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": "Saint Paul",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81244",
      "recalling_firm": "Ecolab Inc",
      "address_1": "1 Ecolab Pl",
      "address_2": "N/A",
      "postal_code": "55102-2739",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - US Nationwide Distribution in the states of AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, AND WY  In the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Iceland, Ireland, Italy, Martinique, Netherlands, Norway, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, and United Kingdom",
      "recall_number": "Z-0233-2019",
      "product_description": "Disposable Accessory Kit, 3-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical    Product Usage:  Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]",
      "product_quantity": "4,861 cases (24,305 eaches)",
      "reason_for_recall": "The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal.  Should there be a channel in the pouch seal it may result in a breach in the sterility of the product.",
      "recall_initiation_date": "20180914",
      "center_classification_date": "20181023",
      "termination_date": "20210212",
      "report_date": "20181031",
      "code_info": "Item 420290-03 Lots # D173047, D173557, D173017, D180127, D172917, D180137, D172827, D172897, D180197A, D172757, D173037, D173557A, D180297, D172907, D180127A, D173207, D172847, D180397, D180037, D180287, D180267, D180197, D180277, D180417, D172787, D180047, D173057, D180407, D172797, D173567,  D180477, and D180607."
    }
  ]
}