# FDA recall Z-1458-2024

> **Covidien, LP** · Class II · device recall initiated 2024-02-14.

## Product

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.

## Distribution

Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan.

## Key facts

- **Recall number:** Z-1458-2024
- **Recalling firm:** Covidien, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-14
- **Report date:** 2024-04-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Haven, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1458-2024

## Citation

> AI Analytics. FDA recall Z-1458-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1458-2024. Source: US FDA. Licensed CC0.

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