{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "185826",
      "product_res_number": "Z-1297-2021",
      "event_date_initiated": "2021-01-29",
      "event_date_created": "2021-03-24",
      "recall_status": "Open, Classified",
      "res_event_number": "87331",
      "product_code": "FQO",
      "product_description": "S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502\nComponents that are affected within the S-Series Finished Good Model Number\no\tP38198 - ASM, MFR CONTROLLER, FIXED STANDARD\no\tP38199 - ASM, MFR CONTROLLER, LIFT STANDARD\no\tP40553 - ASM, MFR HANDLE REPAIR, LIFTING, S-SERIES, STANDARD\no\tP40554 - ASM, MFR HANDLE REPAIR, FIXED, S-SERIES, STANDARD\no\tP46269 - ASSY, MFR CONTROLLER UPGRADE, STANDARD",
      "code_info": "Serial Numbers: 2258046   2863490",
      "firm_fei_number": "3002975342",
      "recalling_firm": "Stryker Communications",
      "address_1": "571 Silveron Blvd",
      "city": "Flower Mound",
      "state": "TX",
      "postal_code": "75028",
      "additional_info_contact": "Saijal Naik\n469-470-4321",
      "reason_for_recall": "The manufacturer has become aware that there is a likelihood that the S-Series Equipment Management System Capacitive Touch Controls on the MFRs rotational electrical magnetic brakes may disengage when an electrocautery device is in use.",
      "root_cause_description": "Under Investigation by firm",
      "action": "An Urgent Customer Notification Letter was mailed (certified) to the affected consignees on 01/29/2021.  \nCustomers will be notified by letter and a Stryker Representative will visit each account for product inspection and replacement. If customers notice any issues prior to inspection, customers should discontinue use and call Technical Support immediately at (866) 841-5663.",
      "product_quantity": "1,393 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, and WY. The country of Canada.",
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        "device_name": "Table, Operating-Room, Ac-Powered",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4960",
        "device_class": "1"
      }
    }
  ]
}