Covidien recalls SIGNIA TRI-STAPLE 2.0 surgical staples that may have missing pin components causing incomplete staple formation, leading to bleeding, infection, or severe complications. Affected units include specific model numbers listed in the recall.
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 surgical staples that may have missing pin components. This can cause incomplete staple formation, leading to bleeding, anastomotic leaks, infections, or serious complications like pneumothorax.
The staples may be missing one of two pin components that keep the device jaws aligned. Without these pins, the staples might not form properly, causing bleeding, leaks in the surgical site, infections, or pneumothorax (collapsed lung).
Surgical patients and healthcare professionals who use the SIGNIA TRI-STAPLE 2.0 staples. Those at highest risk are patients undergoing surgery where these staples are used.
Check for model numbers listed in the recall: N6E0295UX, N6H0576UX, N6J1092UX, N6K0230UX, N6K0938UX, N6L0422URX, N6L0777UX, N6M0607UX, N7A0415UX, N7C0112X, N7D1013X, N7E1089X, N7F0275X, N7F1126X, N7G0444X, N7H0047X, N7H1067X, N7J0175X, N7L0825X, N8A0249X, N8A0655X, N8B0455X, N8B0945X, N8C0757X, N8C1213X, N8D0593X, N8D0907X, N8E0015X, N8G0648X, N8J0764X, N8K0823KY, N8K0840Y, N8L0166Y, N8L0436Y, N8M0845Y, N9A0204Y, N9B0455Y.
Identify if your staple has one of the model numbers listed in the recall: N6E0295UX, N6H0576UX, N6J1092UX, N6K0230UX, N6K0938UX, N6L0422URX, N6L0777UX, N6M0607UX, N7A0415UX, N7C0112X, N7D1013X, N7E1089X, N7F0275X, N7F1126X, N7G0444X, N7H0047X, N7H1067X, N7J0175X, N7L0825X, N8A0249X, N8A0655X, N8B0455X, N8B0945X, N8C0757X, N8C1213X, N8D0593X, N8D0907X, N8E0015X, N8G0648X, N8J0764X, N8K0823KY, N8K0840Y, N8L0166Y, N8L0436Y, N8M0845Y, N9A0204Y, N9B0455Y.
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.
Check if your staple has one of the model numbers listed in the recall. If it does, contact the manufacturer for instructions.
Yes, the missing pin components can cause incomplete staple formation, leading to bleeding, infection, or serious complications like pneumothorax.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1836-2019 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1836-2019 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.
