Signia" Small Diameter Curved Tip Intelligent Reload — Class II medical device recall Z-1457-2024
Ongoing recall by Covidien, LP, reported 2024-04-10, distributed nationwide. Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causin
| Recall number | Z-1457-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LP, North Haven, CT, United States |
| Recall initiated | 2024-02-14 |
| Classified | 2024-04-01 |
| Reported by FDA | 2024-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR, HK, IL, JP |
| Quantity | 30 units |
| UPC / GTIN / UDI-DI | 10884521741881 |
| Lot numbers | N3L1909UY |
| Model numbers | IGSDS30CTVT, SIGSDS30CTVT |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1457-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.