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

Recall Z-0485-2026 — Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;

U.S. FDA — Device Enforcement · United States · 2025-09-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0485-2026
Date of alert
2025-09-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Covidien, LP
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
20884521741840
Reported risk: A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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