Edwards Lifesciences, LLC 2025-07-16 Health critical FDA
Health · FDA · Recall #FDA-Z-2080-2025
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula … Recall
Issued July 16, 2025 · Edwards Lifesciences, LLC
In July 2025, Edwards Lifesciences, LLC recalled the Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula …, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
What you should do
- 1 Stop using Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula … right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Edwards Lifesciences, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Edwards Lifesciences, LLC
- Category
- Health
- Recall date
- July 16, 2025
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution including in the states of ALABAMA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE,
- Recall number
- FDA-Z-2080-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Edwards Lifesciences, LLC has 2 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.