Reported Apr 10, 2024 · Ongoing
Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Covidien, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien, LP · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
- Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
- Lot codes and dates
- Model NumberSIGSDS30CTVT
- UDI/DI10884521741888
- Lot numbers
N3L1909UYN3L1868UYN3L2008UYN3L2221UYN3M1541UYN3M1603UYN3M1639UY
- Amount recalled
- 3,023 units
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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