FDA Enforcement
Class II
Ongoing
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
Recall: Z-0486-2026
·
Reported November 19, 2025
Enforcement
- Recall Number
- Z-0486-2026
- 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); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
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: BOX06170V4; UDI-DI: 00763000988975; Lot numbers: 0231961695;
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
2 units (OUS only)