{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84065",
      "recalling_firm": "Edwards Lifesciences, LLC",
      "address_1": "1 Edwards Way",
      "address_2": "N/A",
      "postal_code": "92614-5688",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Washington DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas,  Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Washington DC, Wisconsin, West Virginia, Wyoming and countries of Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Chile, China, Cyprus, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hungary, Canary Islands, Ireland, India, Iceland, Italy, Japan, Mauritius, Malaysia, Netherlands, Norway, Poland, Romania, Sweden, Singapore, Slovakia, Thailand, Turkey, United Arab Emirates, South Africa.",
      "recall_number": "Z-0420-2020",
      "product_description": "EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8\") 3/8\" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI):   EZC21A (00690103174182),   EZC21TA (00690103174199),   EZC24A (00690103714401),   EZC24TA (00690103714418),   EZF21A (00690103175080),  EZF21TA (00690103175097),  EZF24A (00690103175066),   EZF24TA (00690103175073),   EZS21A (00690103172096),   EZS21TA (00690103172102),   EZS24A  (00690103172119),   and EZS24TA (00690103172126)  Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6 Fr. (2 mm) to 18 Fr. (6 mm) can be used in pediatric patient populations.",
      "product_quantity": "62,431 units",
      "reason_for_recall": "Their is a possibility that the cannula may separate from its connector, potentially causing a breach of circuit during cardiopulmonary bypass which could result in significant blood loss.",
      "recall_initiation_date": "20191022",
      "center_classification_date": "20191118",
      "termination_date": "20220629",
      "report_date": "20191127",
      "code_info": "Lot #s: 203876 207654 217024 226788,205724, 207655, 217025, 226938,205775, 208823, 217048, 227494,205868, 208893, 218185, 227886,205920, 208894, 218457, 228009,205921, 209901, 218539, 228259,205922, 209904, 219090, 228549,206369, 210110, 219212, 228558,206372, 210111, 219561, 229051,206373, 212032 ,220146 ,229054,206374, 212033 ,220151 ,229827,206768, 212034 ,220157 ,230690,206769, 212035 ,220802 ,230894,206770, 212258 ,220803 ,231105,206771, 212280 ,222841 ,231109,206772, 212959 ,222913 ,231111,206773, 213506 ,222914 ,231291,206774, 213914 ,222915 ,231485,206775, 214214 ,223174 ,232109,206776 ,214216 ,224233 ,232437,206777 ,214716 ,224235 ,234138,206778 ,214717 ,224662,207319 ,214961 ,224707,207320 ,215239 ,225306,207321 ,215495 ,225884,207322 ,216123 ,225885,207323 ,216196 ,226188,207324 ,216627 ,226596,207636 ,216628 ,226597,207638 ,216632, 226691"
    }
  ]
}