Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Reported: April 10, 2024 Initiated: February 14, 2024 #Z-1458-2024
Product Description
Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Reason for Recall
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.
Details
- Recalling Firm
- Covidien, LP
- Units Affected
- 3,023 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan.
- Location
- North Haven, CT
Frequently Asked Questions
What product was recalled? ▼
Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT. Recalled by Covidien, LP. Units affected: 3,023 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 10, 2024. Severity: Moderate. Recall number: Z-1458-2024.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11