{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "167453",
      "product_res_number": "Z-0295-2019",
      "event_date_initiated": "2018-08-27",
      "event_date_created": "2018-10-30",
      "recall_status": "Open, Classified",
      "res_event_number": "81106",
      "product_code": "HAB",
      "product_description": "Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System\n\nProduct Usage:\nThe battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.",
      "code_info": "UDI Number 0888867223349; Material Number AR-400UBH;    Batch Numbers:  GB4091590, GB4103994, GB4211089, GB4241346, GB4260648, GB4279490, GB4320568, GB4426191, GB3854432, GB3854434, GB3854435",
      "firm_fei_number": "1220246",
      "recalling_firm": "Arthrex, Inc.",
      "address_1": "1370 Creekside Blvd",
      "city": "Naples",
      "state": "FL",
      "postal_code": "34108-1945",
      "additional_info_contact": "800-933-7001",
      "reason_for_recall": "The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Arthrex notified customers on or about 08/27/2018 via recall letter entitled \"URGENT: VOLUNTARY PRODUCT RECALL NOTIFICATION.\"  The recall letter instructed customers to immediately discontinue use, sale and distribution of the affected product and contact Arthrex Product Surveillance at 866-267-9138 or complaints@arthrex.com as soon as possible to arrange for return of affected product.",
      "product_quantity": "335 devices",
      "distribution_pattern": "Worldwide - Nationwide Distribution in the states of AL, CA, CO, FL, ID, IL, MA, MD, MI, MO, NC, NE, NY, PA, SC, TN, TX, UT, WI.  and the countries of  Austria, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Italy, Kuwait, Lithuania, Netherlands, Norway, Poland, Russia, Slovakia, Spain and Switzerland.",
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        "device_name": "Saw, Powered, And Accessories",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4820",
        "device_class": "1"
      }
    }
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}