FDA Enforcement
Class II
Ongoing
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
Recall: Z-0485-2026
·
Reported November 19, 2025
Enforcement
- Recall Number
- Z-0485-2026
- Event ID
- 97792
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Covidien, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 19, 2025
- Initiation Date
- September 25, 2025
- Classification Date
- November 7, 2025
- Address
- 60 Middletown Ave, North Haven, CT, 06473-3908, United States
Description
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
Reason
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.
Code Info
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.
Quantity
3263 units