Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Tri-Staple 2.0 Black Intelligent Reload Recalled by Covidien, LP Due to Affected lots have the potential for a broken...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Covidien, LP directly.
Affected Products
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
Quantity: 264 US; 5056 OUS
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Covidien, LP
Covidien, LP has 68 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report