Z-1457-2024 Class II Ongoing
FDA device recall Z-1457-2024 was initiated by Covidien, LP on Feb 14, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 30 Units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 10, 2024
- Initiation Date
- Feb 14, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 Units
Product Description
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan.
Code Information
Model Number: SIGSDS30CTVT; UDI/DI: 10884521741881; Lot number: N3L1909UY;
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1457-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026