Covidien, LP 2024-04-10 Health serious FDA
Health · FDA · Recall #FDA-Z-1457-2024
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT Recall
Issued April 10, 2024 · Covidien, LP
In April 2024, Covidien, LP recalled the Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Covidien, LP to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Covidien, LP
- Category
- Health
- Recall date
- April 10, 2024
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan.
- Recall number
- FDA-Z-1457-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Covidien, LP has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.