Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: Recalled by Angiodynamics, Inc. Due to Potential for procedural delays or interruptions during use...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Angiodynamics, Inc. directly.
Affected Products
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Quantity: 138 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Angiodynamics, Inc.
Angiodynamics, Inc. has 74 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report