Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1457-2024 — Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT

U.S. FDA — Device Enforcement · United States · 2024-02-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1457-2024
Date of alert
2024-02-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Covidien, LP
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10884521741881
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.