Lower risk Medical device recall · FDA · Published August 17, 2018

Covidien EEA Circular Stapler Recall: Incorrect Tissue Gap Risk

Covidien recalls EEA Circular Staplers with Tri-Staple Technology due to potential incorrect tissue gap causing incomplete staples or tissue trauma. No serious injuries reported.

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

🇺🇸 FDA recall #Z-0070-2019Medical device Covidien ›

Lower-risk recall

The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury related to this issue.

Take action

Contact the company

Recalling firmCOVIDIEN LLC15 Hampshire St · Mansfield, MA 02048-1113

✎ GovInfoNow plain-language explainer

Covidien is recalling EEA Circular Staplers with Tri-Staple Technology because they might have an incorrect tissue gap. This could lead to incomplete staple formation or difficulty removing the device, potentially causing bleeding or tissue damage. No serious injuries have been reported from this issue. Read more at govinfonow.com/recall/70016-covidien-eea-circular-stapler-recall-incorrect-tissue-gap-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/70016-covidien-eea-circular-stapler-recall-incorrect-tissue-gap-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0070-2019

Cite this page

“Covidien EEA Circular Stapler Recall: Incorrect Tissue Gap Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70016-covidien-eea-circular-stapler-recall-incorrect-tissue-gap-risk. Based on FDA recall #Z-0070-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0070-2019%22&limit=1).

The FDA announced on 2018-08-17 that Covidien LLC is recalling EEA Circular Staplers with Tri-Staple Technology due to the potential for an incorrect tissue gap. This defect may cause incomplete staple formation or inability to remove the device, potentially leading to bleeding, anastomotic leak, or tissue trauma.

How to tell if you have it

Brand: Covidien
Product: EEA Circular Stapler with Tri-Staple Technology
Part Numbers: TRIEEA28MT, TRIEEA28XT, TRIEEA31MT, TRIEEA31XT
Lot Codes: P8A0976X through P8A0981X, P8B1538X through P8B1542X, P8C0032X, P8C0033X, P8C1177X through P8C1181X, P8C1183X, P8D1405X through P8D1411X, P8E1211X through P8E1217X, P8E1304X, P8E1305X
Distribution: US Nationwide in CA, FL, IL, NC, NY, UT; Austria, Belgium, Denmark, Finland, France, Germany, Iceland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Reunion, Spain, Sweden, Switzerland, and United Kingdom

The hazard

Context

GovInfoNow's records show Covidien LLC has 52 other recalls on record since 2017-08-07. Other recent recalls include the Covidien EndoFLIP System recall (2026-05-13) and the Covidien Mon-a-Therm Stethoscope Recall (2026-04-23). Additional recent actions include the Covidien Shiley Disposable Decannulation Plug Recall (2026-04-23), the Covidien V-Loc 90 Wound Closure Device Recall (2026-06-24), the Covidien V-Loc 180 Absorbable Wound Closure Device Recall (2026-06-24), and the Covidien EndoStitch Polysorb Loading Unit Recall (2026-04-15).

How to tell if you have this one

Check for the model numbers TRIEEA28MT, TRIEEA28XT, TRIEEA31MT, or TRIEEA31XT on the stapler. These models were sold with the Tri-Staple Technology.

Brand
Covidien
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Number
Look for the model numbers TRIEEA28MT, TRIEEA28XT, TRIEEA31MT, or TRIEEA31XT on the stapler.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 6 states.

FDA distribution: “Worldwide Distribution - US Nationwide in the states of CA, FL, IL, NC, NY, UT. and the countries of Austria, Belgium, Denmark, Finland, France, Germany, Iceland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Reunion, Spain,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Illinois, New York, North Carolina, Utah.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

Aug 17, 2018Firm started the recall
Oct 4, 2018FDA classified it Class II
Oct 10, 2018Published in FDA’s Enforcement Report
Apr 10, 2020FDA terminated the recall

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/70016-covidien-eea-circular-stapler-recall-incorrect-tissue-gap-risk">Covidien EEA Circular Stapler Recall: Incorrect Tissue Gap Risk (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-0070-2019 (August 17, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0070-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.