Covidien recalls SIGNIA TRI-STAPLE 2.0 Black 60mm devices due to potential missing pin components causing incomplete staples, which may lead to bleeding, infections, 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 Black 60mm surgical staples because some units 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, the staples may not form properly, leading to incomplete closure. This can cause bleeding, infections, or serious complications like peritonitis or pneumothorax.
Surgical patients and healthcare providers who use the SIGNIA TRI-STAPLE 2.0 Black 60mm staples. Those at highest risk are patients undergoing surgery where these staples are used.
Check for the model numbers listed: SIG60AXT, N6C0533UX through N6H0946UX, N6J0040UX, N6K0302UX, N6K0970UX, N6L0152UX, N6M0328UX, N7A0170UX, N7C0475X, N7C1091X, N7C1092X, N7D0104X, N8A0087X, N8D0035X, N8D0225X.
Identify the model number on the device to see if it matches the recalled list.
Reach out to Covidien for guidance on next steps if the device is recalled.
The device may be missing pin components that maintain jaw alignment, leading to incomplete staple formation and potential complications like bleeding or infections.
Incomplete staple formation can cause bleeding, anastomotic leaks, peritonitis, pneumothorax, or infections like sepsis.
Check the model numbers listed in the recall notice: SIG60AXT, N6C0533UX through N6H0946UX, N6J0040UX, N6K0302UX, N6K0970UX, N6L0152UX, N6M0328UX, N7A0170UX, N7C0475X, N7C1091X, N7C1092X, N7D0104X, N8A0087X, N8D0035X, N8D0225X.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1834-2019 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1834-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
