Recall Z-0486-2026
Covidien, LP · initiated September 25, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
Codes / lots: CFN: BOX06170V4; UDI-DI: 00763000988975; Lot numbers: 0231961695;
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.
FDA-determined cause: Process control
Action taken
On September 25, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Customer actions: Identify and quarantine all unused impacted product listed. Return all quarantined devices to Medtronic. If purchased from a distributor, contact your distributor directly to arrange for the return of the devices back to your distributor. Please complete and return the enclosed Customer Confirmation Form. Pass on this notice to all those who need to be aware within your organization or to any organization where the listed affected lots may have been transferred or distributed.
Details
- Recall number
- Z-0486-2026
- Initiated
- September 25, 2025
- Posted by FDA
- November 7, 2025
- Product code
- GDW – Staple, Implantable
- Quantity
- 2 units (OUS only)
- 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.
- Recalling firm
- Covidien, LP, North Haven, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0485-2026 Class II | Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN:…A manufacturing issue could lead to a malformed cover tube press which can lead to internal components'… | 09/25/2025Open, Classified |