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  "name": "Brand Name: Optisite Arterial Cannula  Product Name: Optisite Arterial Cannula  Model/Catalog Number: OPTI18  Software Version: N/A  Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.  Component: No",
  "description": "FDA recall Z-2081-2025 — Edwards Lifesciences, LLC is recalling Brand Name: Optisite Arterial Cannula  Product Name: Optisite Arterial Cannula  Model/Catalog Number: OPTI18  Software Version: N/A  Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.  Component: No (Devices, Class I). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Brand Name: Optisite Arterial Cannula  Product Name: Optisite Arterial Cannula  Model/Catalog Number: OPTI18  Software Version: N/A  Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.  Component: No",
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      "name": "Edwards Lifesciences, LLC"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2081-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2081-2025: Edwards Lifesciences, LLC is recalling Brand Name: Optisite Arterial Cannula  Product Name: Optisite Arterial Cannula  Model/Catalog Number: OPTI18  Software Version: N/A  Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.  Component: No",
      "text": "The FDA logged enforcement record Z-2081-2025: Edwards Lifesciences, LLC is voluntarily recalling Brand Name: Optisite Arterial Cannula  Product Name: Optisite Arterial Cannula  Model/Catalog Number: OPTI18  Software Version: N/A  Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.  Component: No — reason: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-05-14. Affected lots/codes: Lot Code: Model No: OPTI18; UDI: 00690103180565; All lots up to: BSLC9155 Serial Numbers: 130451 130466 130472 130593 130709 130764 130818 130821 130847 130948 130952 131038 131043 131047 131182 131193 131231 131236 131289 131311 131317 131433 131435 131513 131516 131553 131554 131606 131623 131625 131628 131682 131737 131909 131929 131966 132175 132201 132366 132395 132416 132430 132435 132505 132832 132958 132959 BSLC0110 BSLC0166 BSLC0661 BSLC0661 BSLC0826 BSLC0826 BSLC0826 BSLC0826 BSLC0855 BSLC0855 BSLC0887 BSLC0887 BSLC0979 BSLC1114 BSLC1114 BSLC1211 BSLC1308 BSLC1469 BSLC1656 BSLC1660 BSLC1815 BSLC3221 BSLC4153 BSLC4400 BSLC4461 BSLC4513 BSLC5027 BSLC5027 BSLC5320 BSLC5367 BSLC5765 BSLC6421 BSLC6467 BSLC7335 BSLC7514 BSLC7515 BSLC8175 BSLC8385 BSLC8535 BSLC8657 BSLC9100 BSLC9104 BSLC9105 BSLC9152 BSLC9155. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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      "name": "FDA classified recall Z-2081-2025 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
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        "value": "Class I",
        "adjudicator": {
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      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
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      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
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      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
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            "Status": "recorded"
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            "Value": "Devices",
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            "Field": "Reason",
            "Value": "due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2025-05-14",
            "Status": "recorded"
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            "Value": "Lot Code: Model No: OPTI18; UDI: 00690103180565; All lots up to: BSLC9155 Serial Numbers: 130451 130466 130472 130593 130709 130764 130818 130821 130847 130948 130952 131038 131043 131047 131182 131193 131231 131236 131289 131311 131317 131433 131435 131513 131516 131553 131554 131606 131623 131625 131628 131682 131737 131909 131929 131966 132175 132201 132366 132395 132416 132430 132435 132505 132832 132958 132959 BSLC0110 BSLC0166 BSLC0661 BSLC0661 BSLC0826 BSLC0826 BSLC0826 BSLC0826 BSLC0855 BSLC0855 BSLC0887 BSLC0887 BSLC0979 BSLC1114 BSLC1114 BSLC1211 BSLC1308 BSLC1469 BSLC1656 BSLC1660 BSLC1815 BSLC3221 BSLC4153 BSLC4400 BSLC4461 BSLC4513 BSLC5027 BSLC5027 BSLC5320 BSLC5367 BSLC5765 BSLC6421 BSLC6467 BSLC7335 BSLC7514 BSLC7515 BSLC8175 BSLC8385 BSLC8535 BSLC8657 BSLC9100 BSLC9104 BSLC9105 BSLC9152 BSLC9155",
            "Status": "recorded"
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        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution including in the states of ALABAMA, ARIZONA,  ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA,  FLORIDA, GEORGIA, HAWAII, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS, KENTUCKY,  LOUISIANA, MAINE, MARYLAND, MASSACHUSETTS, MICHIGAN, MINNESOTA, MISSISSIPPI,  MISSOURI, MONTANA, NEBRASKA, NEVADA, NEW HAMPSHIRE, NEW JERSEY, NEW MEXICO,  NEW YORK, NORTH CAROLINA, NORTH DAKOTA, OHIO, OKLAHOMA, OREGON, PENNSYLVANIA, Puerto Rico, RHODE ISLAND, SOUTH CAROLINA, SOUTH DAKOTA, TENNESSEE, TEXAS, UTAH, VIRGINIA, WASHINGTON, WEST VIRGINIA, WISCONSIN and the countries of Albania, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, CANARY ISLANDS, Chile, Colombia, Cyprus, Czech Republic, Denmark, France, Germany, Greece,  Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Malta,  Netherlands, Northern Ireland, Norway, Pakistan, Panama, Poland, Portugal, Romania,  Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan,  Thailand, United Arab Emirates (UAE), United Kingdom.",
            "Status": "recorded"
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}