Stop using now Medical device recall · FDA · Published January 25, 2023

Covidien Tri-Staple 2: Risk of broken sled vane causing tissue damage

Covidien recalls Tri-Staple 2.0 Black Intelligent Reload (SIG60AXT) due to potential broken sled vane causing misfire and tissue damage. Affected lots may lead to delayed treatment, bleeding, or death.

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

🇺🇸 FDA recall #Z-1228-2023Medical device Covidien ›

Stop using this now

Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may be associated to a delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sepsis, pneumothorax, tissue trauma, or death.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Covidien is recalling Tri-Staple 2.0 Black Intelligent Reload devices with specific product numbers because a broken sled vane can cause the device to misfire. This may result in tissue damage, bleeding, or death if the device fails to properly close the staple line during surgery. Read more at govinfonow.com/recall/59009-covidien-tri-staple-2-risk-of-broken-sled-vane-causing.

Source Summary by GovInfoNow · govinfonow.com/recall/59009-covidien-tri-staple-2-risk-of-broken-sled-vane-causing · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1228-2023

Cite this page

“Covidien Tri-Staple 2: Risk of broken sled vane causing tissue damage.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59009-covidien-tri-staple-2-risk-of-broken-sled-vane-causing. Based on FDA recall #Z-1228-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1228-2023%22&limit=1).

The FDA announced on Jan. 25, 2023, that Covidien, LP is recalling the Tri-Staple 2.0 Black Intelligent Reload due to a potential broken sled vane. This defect may cause the device to misfire, leading to serious medical complications including hemorrhage or death.

How to tell if you have it

Brand: Covidien
Product: Tri-Staple 2.0 Black Intelligent Reload
Product Number: SIG60AXT
Lot codes: N2D0002Y, N2D0004Y, N2D0195Y

The hazard

According to the FDA, affected lots have the potential for a broken sled vane which may cause the reload to misfire. This can lead to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may be associated with delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sepsis, pneumothorax, tissue trauma, or death.

Context

GovInfoNow's records show Covidien, LP has 26 other recalls on record since 2017-07-17. Other recent recalls of similar products include Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (2026-03-03), Howmedica TRIATHLON Hinge Insert Recall (2026-07-30), and DeRoyal Covaderm Plus Dressing Recall (2026-05-18).

How to tell if you have this one

Check for the product number SIG60AXT on the device. Affected lots are N2D0002Y, N2D0004Y, and N2D00195Y. The device was sold with UDI-DI (GTIN) 20884521543598.

Brand
Covidien
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop using it now
Immediately stop using the Tri-Staple 2.0 Black Intelligent Reload device if it has the affected product numbers.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 10 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, New York, North Carolina, Ohio, Washington and the countries of Australia, Austria, Belgium, Canada,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, New York, North Carolina, Ohio, Washington.

Recall timeline

FDA published this recall 49 days after the firm started it.

Jan 25, 2023Firm started the recall
Mar 6, 2023FDA classified it Class II
Mar 15, 2023Published in FDA’s Enforcement Report

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

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/59009-covidien-tri-staple-2-risk-of-broken-sled-vane-causing">Covidien Tri-Staple 2: Risk of broken sled vane causing tissue damage (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-1228-2023 (January 25, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1228-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.