Z-0485-2026 Class II Ongoing
FDA device recall Z-0485-2026 was initiated by Covidien, LP on September 25, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 3263 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 19, 2025
- Initiation Date
- September 25, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3263 units
Product Description
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
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.
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.
Code Information
CFN: SIGSDL45CTVT; UDI-DIs: (1) 20884521741840, (2) 10884521741843; Lot numbers: N5F1971Y, N5F1723Y, N5D1858UY, N5B1134UY;