Covidien recalls SIGNIA TRI-STAPLE 2.0 Black 45mm devices due to potential missing pin components causing incomplete staple formation, which may lead to bleeding, infection, or severe 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 Black 45mm surgical staples because they might be missing critical pin components. This could cause incomplete staple formation, leading to bleeding, infections, or serious complications like peritonitis or pneumothorax.
The staples may have missing pin components that prevent proper alignment of the device jaws. This can result in incomplete staple formation, causing bleeding, anastomotic leaks, infections, or severe complications like peritonitis or pneumothorax.
Surgical patients and medical professionals using the SIGNIA TRI-STAPLE 2.0 Black 45mm staples. Those at highest risk are patients undergoing surgery where these staples are used.
Check for the model numbers listed: SIG45AXT, N6E0176UX through N6K1110UX, N7C0111X through N7D0303X. These staples are sold under the brand Covidien.
Immediately stop using the SIGNIA TRI-STAPLE 2.0 Black 45mm staples if you have them.
The affected model numbers are SIG45AXT, N6E0176UX through N6K1110UX, N7C0111X through N7D0303X.
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.
Stop using them immediately and contact Covidien for further instructions.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1833-2019 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1833-2019 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.
