Covidien recalls specific Signia Small Diameter Curved Tip Intelligent Reloads (Model SIGSDS30CTVT) due to potential uncontrolled articulation during use, which could disrupt staple lines. Affected units include certain lot numbers and UDI/DI codes.
Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.
Covidien is recalling specific Signia Small Diameter Curved Tip Intelligent Reloads because they can move unpredictably during use, potentially disrupting surgical staple lines. This hazard affects the Endo GIA Ultra Universal Stapler and Signia Stapling System.
The reloads can move unexpectedly during use due to components that aren't fully secure. This uncontrolled movement might disrupt the surgical staple line, which could lead to complications during procedures.
Surgical professionals using the Endo GIA Ultra Universal Stapler or Signia Stapling System with the recalled reloads are most at risk. Patients undergoing surgery with these devices may be affected if the reloads malfunction.
Check for the model number SIGSDS30CTVT on the reload. Affected units include lot numbers N3L1909UY, N3L1868UY, N3L2008UY, N3L2221UY, N3M1541UY, N3M1603UY, and N3M1639UY. The UDI/DI code 10884521741888 also identifies these units.
Identify the model number and lot numbers to confirm if your reload is affected.
The model number is SIGSDS30CTVT.
The recalled reloads are used with the Endo GIA Ultra Universal Stapler or Signia Stapling System.
Affected lot numbers include N3L1909UY, N3L1868UY, N3L2008UY, N3L2221UY, N3M1541UY, N3M1603UY, and N3M1639UY.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1458-2024 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1458-2024 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.
