Covidien, LP: Medical Device Recall in 2025 - (Recall #: Z-0485-2026)

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:

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

Product Classification:

Class II

Date Initiated: September 25, 2025

Date Posted: November 19, 2025

Recall Number: Z-0485-2026

Event ID: 97792

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 3263 units

Code Information:

CFN: SIGSDL45CTVT; UDI-DIs: (1) 20884521741840, (2) 10884521741843; Lot numbers: N5F1971Y, N5F1723Y, N5D1858UY, N5B1134UY;

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated