Covidien, LP: Device Recall
Recall #Z-0486-2026 · 09/25/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0486-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Covidien, LP
- Status
- Ongoing
- Date Initiated
- 09/25/2025
- Location
- North Haven, CT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units (OUS only)
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.
Product Description
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
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.
Other Recalls by Covidien, LP
- Class II: Risk 09/25/2025
- Class II: Risk 09/19/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.