FDA Device recall Z-1457-2024
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
- FDA Device
- Class II
- ongoing
- Published 2024-04-10
On 2024-04-10 the FDA classified a Class II recall of Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT by Covidien, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1457-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-14 |
| Published | 2024-04-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Covidien |
| Distribution | US |
Product
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Reason
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.
Identifiers
| code_info | Model Number: SIGSDS30CTVT; UDI/DI: 10884521741881; Lot number: N3L1909UY; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1457-2024%22
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