Covidien, LP recalls Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;

Recall date

September 25, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0485-2026

FDA classification

Class II

Brand / firm

Covidien, LP

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Chile, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Kuwait, Malaysia, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, United Kingdom.

Why it was recalled

A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;