{
  "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": {
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  "results": [
    {
      "cfres_id": "210771",
      "product_res_number": "Z-0484-2025",
      "event_date_initiated": "2024-10-16",
      "event_date_posted": "2024-11-18",
      "recall_status": "Open, Classified",
      "res_event_number": "95614",
      "product_code": "MWS",
      "product_description": "Acrobat-i Positioner. Model Number C-XP-5000Z",
      "code_info": "Model Number C-XP-5000Z. UDI-DI Number: 00607567500006. Batch Numbers: 3000272452, 3000289270, 3000293675, 3000340401, 3000382289, 3000282355, 3000287205, 3000290368, 3000306921, 3000308238, 3000307458, 3000318694, 3000282741, 3000290350, 3000306394, 3000334128, 3000355318, 3000362345, 3000278266, 3000343467, 3000353846, 3000346421, 3000360292, 3000364706, 3000317546, 3000272461, 3000343116, 3000360175, 3000360569, 3000355540, 3000380141, 3000378810, 3000334322, 3000363049, 3000311731, 3000306920, 3000365139, 3000273855, 3000300092, 3000276339, 3000347351, 3000347358, 3000352249, 3000397151, 3000368288, 3000293958, 3000288356, 3000286557, 3000402809, 3000392590, 3000340972.",
      "firm_fei_number": "2242352",
      "recalling_firm": "Maquet Cardiovascular, LLC",
      "address_1": "45 Barbour Pond Dr",
      "city": "Wayne",
      "state": "NJ",
      "postal_code": "07470-2094",
      "additional_info_contact": "Stephanie Moretti\n973-709-7000",
      "reason_for_recall": "Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.",
      "root_cause_description": "Process change control",
      "action": "MAQUET Cardiovascular LLC / Getinge notified consignees via letter FedEx 2-Day Delivery on 10/16/2024. Customers were instructed to forward the notification to all users and notify customers if further distributed, examine inventory and return any affected inventory, and to complete and return the MEDICAL DEVICE REMOVAL - RESPONSE FORM.",
      "product_quantity": "14,338 units",
      "distribution_pattern": "Nationwide distribution.  International distribution to Albania, Algeria, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brunei Canada, Croatia, Czech Republic, Denmark, Finland, France and Belarus, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Lebanon, Luxembourg, Malaysia, Netherlands, Oman, Pakistan, Poland, Portugal, Slovenia, South Africa, Spain, Switzerland, the Republic of Korea (South Korea), Turkey, United Arab Emirates, United Kingdom.",
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        "device_name": "Stabilizer, Heart",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4500",
        "device_class": "1"
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