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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Covidien Signia Intelligent Reloads Recalled for Firing Defect

Agency Publication Date: November 7, 2025
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Summary

Covidien, LP is recalling 3,265 units of Signia Small Diameter Curved Tip Intelligent Reloads (45mm Vascular/Thin) due to a manufacturing defect. A component called the cover tube press may be malformed, which can allow internal parts to move while the device is being used. This defect can lead to uncontrolled motion when the device is fired during a procedure.

Risk

The uncontrolled motion of internal components during device firing can cause the surgical tool to behave unpredictably, potentially resulting in unintended tissue damage or other surgical complications.

What You Should Do

  1. This recall involves Covidien Signia Small Diameter Curved Tip Intelligent Reloads (45mm Vascular/Thin) with catalog numbers SIGSDL45CTVT and BOX06170V4.
  2. Identify if your device is affected by checking for lot numbers N5F1971Y, N5F1723Y, N5D1858UY, N5B1134UY, or 0231961695 on the product packaging.
  3. Stop using the recalled device immediately.
  4. Contact Covidien, LP or your authorized distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional information or to report a consumer complaint.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Covidien Signia Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin)
Model / REF:
SIGSDL45CTVT
Lot Numbers:
N5F1971Y
N5F1723Y
N5D1858UY
N5B1134UY
UDI:
20884521741840
10884521741843

Quantity: 3263 units

Product: Covidien Signia Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin) BOX LOBECTOMIA VATS 3D
Model / REF:
BOX06170V4
Lot Numbers:
0231961695
UDI:
00763000988975

Quantity: 2 units (OUS only)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97792
Status: Active
Manufacturer: Covidien, LP
Sold By: Medical distributors; Surgical centers; Hospitals
Manufactured In: United States
Units Affected: 2 products (3263 units; 2 units (OUS only))
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.