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

Recall Z-0770-2025 — AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100

U.S. FDA — Device Enforcement · United States · 2024-11-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0770-2025
Date of alert
2024-11-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Angiodynamics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07290017590110
Reported risk: Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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