Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula
Medical device recall Z-2081-2025. Published in FDA’s Enforcement Report on Jul 16, 2025.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 16, 2025. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 49 states named
- 13240 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
13240, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 823 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
49 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- 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
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 14, 2025.
- FDA classified it on Jul 10, 2025.
- FDA’s Enforcement Report published it on Jul 16, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Edwards Lifesciences, LLC, of Irvine, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.