Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;

FDA Recall Z-0486-2026 · Posted 2025-11-07

Recalling FirmCovidien, LP
Recall StatusOpen, Classified
Product CodeGDW
Date Initiated2025-09-25
Product Quantity2 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.

Firm 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.

Root Cause

Process control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K191070Signia Small Diameter ReloadsCovidien · 2019-09-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑