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Use caution Medical device recall · FDA · Published September 15, 2017

Covidien Endo GIA Radial Reload Tri-Staple: Cartridge Disengagement Risk

Covidien recalls Endo GIA Radial Reload with Tri-Stap: Cartridge disengagement due to manufacturing error. Affected units have product number EGIARADXT and lot code N6L0351X.

🇺🇸 FDA recall #Z-0908-2018Medical deviceCovidien ›
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Recalling firmCovidien LLC60 Middletown Ave · North Haven, CT 06473-3908
✎ GovInfoNow plain-language explainer

What happened, in plain English

Covidien is recalling Endo GIA Radial Reload with Tri-Staple Technology devices because a manufacturing error caused the cartridge to disengage during use. This could lead to complications during surgery if the device fails mid-procedure. Read more at govinfonow.com/recall/73016-covidien-endo-gia-radial-reload-tri-staple-cartridge-disengagement-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/73016-covidien-endo-gia-radial-reload-tri-staple-cartridge-disengagement-risk · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0908-2018

Cite this page

“Covidien Endo GIA Radial Reload Tri-Staple: Cartridge Disengagement Risk.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/73016-covidien-endo-gia-radial-reload-tri-staple-cartridge-disengagement-risk. Based on FDA recall #Z-0908-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0908-2018%22&limit=1).

Why it’s dangerous

The device cartridge can become detached during surgery due to a manufacturing defect. This disengagement could cause the device to malfunction or fail mid-procedure, potentially leading to complications in tissue resection or anastomosis.

Who’s affected

Surgical teams using the Endo GIA Radial Reload with Tri-Staple Technology for abdominal, gynecologic, or thoracic procedures are affected. Surgeons and medical staff who use these devices during operations are at risk.

How to tell if you have this one

Check for product number EGIARADXT and lot code N6L0351X on the device. These specific units were recalled due to a manufacturing error.

  • Brand
    Covidien
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Details

    Look for product number EGIARADXT and lot code N6L0351X on the device packaging or label.

How this recall unfolded

Recall timeline

FDA terminated this recall 15 months after the firm started it.

1. Firm started the recall: Sep 15, 201712. FDA classified it Class II: Mar 5, 201823. Published in FDA’s Enforcement Report: Mar 14, 201834. FDA terminated the recall: Dec 19, 2018420172018
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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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-0908-2018 (September 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0908-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA