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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, LP: Tri-Staple 2.0 Intelligent Reloads Recalled for Potential Cartridge Damage

Agency Publication Date: May 24, 2024
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Summary

Approximately 1,681 units of the Tri-Staple 2.0 Black Reinforced Intelligent Reload (Model SIGTRSB60AXT) have been recalled because of potential damage to the device cartridge. This medical device is used during abdominal, gynecologic, pediatric, and thoracic surgeries for cutting and stapling tissue. A damaged cartridge can lead to poor staple formation or an incomplete staple line, which may cause complications or delays during surgery while medical staff address the failure. This recall specifically affects product lot N3G1372Y.

Risk

A damaged cartridge can cause staples to form incorrectly or leave a staple line incomplete, potentially leading to tissue leakage, bleeding, or significant delays in surgery.

What You Should Do

  1. Identify if you have the Tri-Staple 2.0 Black Reinforced Intelligent Reload by checking the packaging for Model Number SIGTRSB60AXT.
  2. Check the product labels for Lot Number N3G1372Y and GTINs 10884521717633 or 20884521717630 to confirm if your device is affected.
  3. Immediately stop using and quarantine any products identified from the affected lot to ensure they are not used in surgical procedures.
  4. Contact your healthcare provider or the manufacturer, Covidien, LP at 60 Middletown Ave, North Haven, CT for further instructions regarding the return or replacement of these devices.
  5. For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider or manufacturer contact

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Tri-Staple 2.0 Black Reinforced Intelligent Reload
Model / REF:
SIGTRSB60AXT
UPC Codes:
10884521717633
20884521717630
Lot Numbers:
N3G1372Y

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94484
Status: Active
Manufacturer: Covidien, LP
Sold By: Authorized medical distributors; Specialty healthcare providers
Manufactured In: United States
Units Affected: 1681 units
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.