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Home › FDA recalls › Covidien Signia" Small Diameter Curved Tip Intelligent Reloa
CLASS II · ModerateFDA

Covidien, LP recalls Covidien Signia" Small Diameter Curved Tip Intelligent Reload

📅 Sep 25, 2025 · 📍 Nationwide
Recalling company
Covidien, LP
Product
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Sep 25, 2025
Reported
Nov 19, 2025
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.
Status
Ongoing
Quantity
2 units (OUS only)
Lot / codes
CFN: BOX06170V4; UDI-DI: 00763000988975; Lot numbers: 0231961695;
Company location
North Haven, CT
Recall type
Voluntary: Firm initiated
Recall number
Z-0486-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0486-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.