Class II — Covidien, LP
| Recalling firm | Covidien llc |
|---|---|
| Registered facility | View this company's 22 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT |
| Quantity | 3,023 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan. |
| Initiated | 2024-02-14 |
| Classified | 2024-04-01 |
| Recall number | Z-1458-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Covidien, LP (Z-1458-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94128/
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