Edwards Lifesciences, LLC: Medical Device Recall in 2025 - (Recall #: Z-2080-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 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.

Product Classification:

Class I

Date Initiated: May 14, 2025

Date Posted: July 16, 2025

Recall Number: Z-2080-2025

Event ID: 96943

Reason for Recall:

due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.

Status: Ongoing

Product Quantity: 27022

Code Information:

Lot Code: Model No:OPTI16; UDI: 00690103180558; All lots up to BSLC9149 Serial Numbers: 130467 130471 130602 130765 130816 130822 130852 130949 131039 131041 131044 131237 131312 131428 131509 131826 131887 131908 132338 132436 132503 132831 BSLC0040 BSLC0165 BSLC0165 BSLC0320 BSLC1309 BSLC1309 BSLC1468 BSLC1468 BSLC1557 BSLC1682 BSLC1688 BSLC1825 BSLC1830 BSLC5302 BSLC5899 BSLC6166 BSLC7142 BSLC7142 BSLC7513 BSLC8176 BSLC8659 BSLC9149

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated