Use caution Medical device recall · FDA · Published September 25, 2025

Covidien Signia Small Diameter Curved Tip Recall: Risk of Uncontrolled Motion

Covidien recalls specific Signia small diameter curved tip intelligent reload devices due to potential uncontrolled motion from manufacturing issues. Affected units may require replacement to prevent internal component movement.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0486-2026Medical device Covidien ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmCovidien, LP60 Middletown Ave · North Haven, CT 06473-3908

✎ GovInfoNow plain-language explainer

Covidien is recalling certain Signia small diameter curved tip intelligent reload devices because a manufacturing issue could cause internal components to move unexpectedly during use. This poses a risk of uncontrolled motion that might affect medical procedures. Read more at govinfonow.com/recall/51223-covidien-signia-small-diameter-curved-tip-recall-risk-of-uncontrolled.

Source Summary by GovInfoNow · govinfonow.com/recall/51223-covidien-signia-small-diameter-curved-tip-recall-risk-of-uncontrolled · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0486-2026

Cite this page

“Covidien Signia Small Diameter Curved Tip Recall: Risk of Uncontrolled Motion.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51223-covidien-signia-small-diameter-curved-tip-recall-risk-of-uncontrolled. Based on FDA recall #Z-0486-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0486-2026%22&limit=1).

The FDA announced on Sept. 25, 2025, that Covidien, LP is recalling two units of the Covidien Signia Small Diameter Curved Tip Intelligent Reload due to a manufacturing issue causing potential uncontrolled motion. According to the FDA, the hazard stems from a malformed cover tube press.

How to tell if you have it

Brand: Covidien
Product: Covidien Signia Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D
CFN: BOX06170V4
UDI-DI: 00763000988975
Lot numbers: 0231961695
Quantity: 2 units (OUS only)

The hazard

According to the FDA, 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.

Context

GovInfoNow's records show Covidien, LP has 26 other recalls on record since 2017-07-17. Other recent recalls of similar products include Covidien Dermalon 4-0 Blue 75cm Sutures Recall (2026-06-24), Covidien EndoStitch Polysorb Loading Unit Recall (2026-04-15), and Covidien Chameleon PTA Balloon Catheter Recall (2024-09-19). Other recent recalls of similar products include Merit Medical Custom Procedure Kit Recall (2025-12-04), CleverCut Single Use Sphincterotome V Recall (2026-01-07), and Canon Alphenix INFX-8000F X-Ray System Recall (2025-12-19).

How to tell if you have this one

Check for the product name 'Covidien Signia Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin)'. The lot numbers 0231961: 0231961695 and box codes BOX06170V4 indicate the affected units.

Brand
Covidien
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
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.

Recall number	Product, codes & lots	Quantity
Z-0485-2026	Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;; CFN: SIGSDL45CTVT; UDI-DIs: (1) 20884521741840, (2) 10884521741843; Lot numbers: N5F1971Y, N5F1723Y, N5D1858UY, N5B1134UY;	3263 units
Z-0486-2026	Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;; CFN: BOX06170V4; UDI-DI: 00763000988975; Lot numbers: 0231961695;	2 units (OUS only)

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the product name and lot numbers to confirm if your device is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 55 days after the firm started it.

Sep 25, 2025Firm started the recall
Nov 7, 2025FDA classified it Class II
Nov 19, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/51223-covidien-signia-small-diameter-curved-tip-recall-risk-of-uncontrolled">Covidien Signia Small Diameter Curved Tip Recall: Risk of Uncontrolled Motion (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0486-2026 (September 25, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0486-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.