{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Ann Arbor",
      "address_1": "6200 Jackson Rd",
      "reason_for_recall": "During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of  loose fiber particulate that exceeded finished product specifications",
      "address_2": "",
      "product_quantity": "7,460 units",
      "code_info": "Part No. 165269, Lot #: 0649648, 0652316, 0653402, 0659824, 0678725, 0682564; Part No. 9482, Lot #: 0653227, 0656440, 0673777; Part No. 4344, Lot #: 0645166, 0653856, 0673024; Part No. 9485, Lot #: 654068; Part No. 9486, Lot #: 649867; Part No. 4400, Lot #: 0650491, 0659436, 0669133, 0674461; Part No. 165267, Lot #: 0654562, 0672209, 0676284, 0678213; Part No. 165266, Lot #: 0658973, 0661133, 0667798, 0675018, 0678084; Part No. 9483, Lot #: 0649709, 0653442, 0655043; Part No. 4460, Lot #: 0667803, 0675761, 0677655; Part No. 165765, Lot #: 677007; Part No. 165265, Lot #: 0652644, 0659820, 0674746, 0683956; Part No. 165264, Lot #: 0646481, 0650489, 0653235, 0668894, 0676282, 0681876, 0683955 & Part No. 9484, Lot #: 0649158, 0655040, 0660676.",
      "center_classification_date": "20140722",
      "distribution_pattern": "Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, 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, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.",
      "state": "MI",
      "product_description": "Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer    Product Usage:  The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.",
      "report_date": "20140730",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "recall_number": "Z-2094-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "68404",
      "termination_date": "20150224",
      "more_code_info": "",
      "recall_initiation_date": "20140523",
      "postal_code": "48103-9586",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}