Lower riskMedical device recall · FDA · Published April 15, 2024
Covidien Tri-Staple 2: Risk of poor staple formation during surgery
Covidien recalls Tri-Staple 2.0 Black Reinforced Intelligent Reload cartridges for potential poor staple formation, which may delay surgery. Affected units have specific model and lot numbers.
“Covidien Tri-Staple 2: Risk of poor staple formation during surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55406-covidien-tri-staple-2-risk-of-poor-staple-formation-during. Based on FDA recall #Z-1891-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1891-2024%22&limit=1).
The FDA announced on April 15, 2024, that Covidien, LP is recalling Tri-Staple 2.0 Black Reinforced Intelligent Reload surgical devices due to potential cartridge damage causing poor staple formation. The agency issued recall number Z-1891-2024 for the Class II voluntary recall.
How to tell if you have it
Brand: Covidien
Product: Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic
Model: SIGTRSB60AXT
UPC: 10884521717633
UPC: 4521717630
Lot #: N3G1372Y
The hazard
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, which may cause a delay in surgery. The FDA stated this hazard as part of the recall description.
Context
GovInfoNow's records show Covidien, LP has 26 other recalls on record since July 17, 2017. Recent brand recalls include Surgipro SP-623 Sutures (June 24, 2026), EndoStitch Polysorb Loading Unit (April 15, 2026), and Signia Small Diameter Curved Tip (Sept. 25, 2025). Other recent recalls of similar products include Intuitive 8 mm SureForm 30 Gray Reloads (March 11, 2026), DeRoyal Covaderm Plus Dressing (May 18, 2026), and F & A Foundation Reign Medical Clench Staple System (July 15, 2026).
How to tell if you have this one
Check for model number SIGTRSB60AXT or GTINs 10884521717633 and 10884521717630. Lot numbers N3G1372Y are also associated with this recall.
Brand
Covidien
Product
Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Cartridge Model
Look for model number SIGTRSB60AXT or GTINs 10884521717633 and 10884521717630 on the cartridge packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the state of NJ and the countries of Australia, Japan, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 51 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1891-2024 (April 15, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1891-2024 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.