{
  "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,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "220291",
      "product_res_number": "Z-2575-2026",
      "event_date_initiated": "2026-05-12",
      "event_date_posted": "2026-06-24",
      "recall_status": "Open, Classified",
      "res_event_number": "98966",
      "product_code": "MWS",
      "product_description": "Octopus Evolution Tissue Stabilizer, Model TS2000",
      "code_info": "UDI-DI: 00643169668911;\nSerial Numbers: 0232992409\n0233010063\n0233010115",
      "firm_fei_number": "1000116158",
      "recalling_firm": "Medtronic Perfusion Systems",
      "address_1": "7611 Northland Dr N",
      "city": "Brooklyn Park",
      "state": "MN",
      "postal_code": "55428-1088",
      "additional_info_contact": "Medtronic Customer Service\n800-854-3570",
      "reason_for_recall": "During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.",
      "root_cause_description": "Under Investigation by firm",
      "action": "An URGENT: MEDICAL DEVICE RECALL notification letter dated 5/12/26 was sent to customers.\n\nCustomer Actions:\nMedtronic requests that you take the following actions:\n\" Review your inventory for lot numbers listed in Attachment A.\n\" If you have unused inventory from the listed lot numbers, immediately quarantine and return the products to Medtronic by contacting Customer Service at 1-800-854-3570, Option 1 then Option 4, and referencing this communication to initiate return and exchange or credit of this unit. Your Medtronic sales representative can assist you in the return of unit as necessary.\n\" Complete the enclosed Customer Confirmation Form and email to RS.CFQFCA@medtronic.com. This form must be returned even if you do not have the affected product in your possession.\n\" Please share this notification with others in your organization as appropriate. If product listed above has been forwarded to another facility, please notify the facility of this Medtronic Urgent Medical Device Recall.\n\" Please maintain a copy of this communication in your records.\nIf you have any questions regarding this communication, please contact Medtronic Field Representative.",
      "product_quantity": "134 units",
      "distribution_pattern": "Worldwide - US Nationwide distribution.",
      "openfda": {
        "k_number": [
          "K992476",
          "K982419",
          "K992833",
          "K041338"
        ],
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          "1000306431",
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          "3000215205",
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        ],
        "device_name": "Stabilizer, Heart",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4500",
        "device_class": "1"
      }
    }
  ]
}