Recall Z-0485-2026 · GDW Staple, Implantable
Covidien, LP
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
| Date | Nov 7, 2025 (initiated Sep 25, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 3263 units |
| 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. |
| FDA record | Open on fda.gov |