FDA DeviceNov 19, 2025Class II

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

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.

From the FDA notice · Read the official notice ↗ · All Covidien recalls

What to do

The agency's notice has the remedy and who to contact.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
Sold in: Nationwide
Made for: All ages (0 months and older)

This recall covers 2 products — see all of them.

Details

Units affected: 3263 units
Illnesses reported: None reported
Manufactured in: 60 Middletown Ave, North Haven, CT, United States
Classification: Class II
Recall number: Z-0485-2026

In the FDA's words

Description: Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT; 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. CFN: SIGSDL45CTVT; UDI-DIs: (1) 20884521741840, (2) 10884521741843; Lot numbers: N5F1971Y, N5F1723Y, N5D1858UY, N5B1134UY; Distribution: 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. Affected quantity: 3263 units
Hazard: 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.

2 products in this recall

Covidien Signia staplers recalled for uncontrolled motion risk

Covidien is recalling two Signia small diameter curved tip intelligent reloads because a manufacturing issue can cause a malformed cover tube press. This can let internal components move during firing, creating a risk of uncontrolled motion. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT; (this page)
Z-0485-2026 · 3263 units
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
Z-0486-2026 · 2 units (OUS only)