Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VenaSeal Recalled by Covidien LLC Due to Possible sterility breach of the outer packaging (pouch)...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Covidien LLC directly.
Affected Products
VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
Quantity: 1661 units
Why Was This Recalled?
Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.
Where Was This Sold?
Worldwide distribution. No U.S. accounts; Australia, Canada, France, Germany, Hong Kong, Ireland, Italy, Latvia, Netherlands, Norway, Portugal, Switzerland, UAE and the United Kingdom.
About Covidien LLC
Covidien LLC has 248 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report