Covidien recalls SIGNIA TRI-STAPLE 2.0 30MM reloads due to potential missing pin components causing incomplete staple formation, which may lead to bleeding, infection, or serious complications.
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
Covidien is recalling SIGNIA TRI-STAPLE 2.0 30MM medium/thick reload staples because they may have missing pin components that cause incomplete staple formation. This can lead to bleeding, infections, or serious complications like peritonitis or pneumothorax.
The device may be missing one of two pin components that keep the staple jaws aligned. Without these pins, staples may not form properly, leading to bleeding, anastomotic leaks, infections, or serious complications like peritonitis or pneumothorax.
Surgical professionals and patients who have received these specific staple reloads during procedures. Those using the product in high-risk surgical settings are most at risk.
Check for the model numbers listed in the recall: N6E0033UX through N9A0427Y. These are specific SIGNIA TRI-STAPLE 2.0 30MM medium/thick reload staples sold under the product code SIG30AMT.
Verify the model number on the staple package to see if it matches the listed numbers: N6E0033UX through N9A0427Y.
Reach out to Covidien directly for guidance on next steps if you have the recalled product.
The recalled model numbers are N6E0033UX through N9A0427Y for SIGNIA TRI-STAPLE 2.0 30MM medium/thick reloads.
The device may be missing pin components that maintain jaw alignment, leading to incomplete staple formation and potential complications like bleeding or infections.
The recall does not specify an immediate stop-use instruction; however, you should check if your product is affected and contact Covidien for guidance.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1832-2019 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1832-2019 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
