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Z-0486-2026Class II

Covidien, LP

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Covidien, LP
Product type
Device
Status
Ongoing
Report date
2025-11-19
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.
Firm state
CT
Product quantity
2 units (OUS only)
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
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;

Code / lot info

CFN: BOX06170V4; UDI-DI: 00763000988975; Lot numbers: 0231961695;

Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →