Lower risk Medical device recall · FDA · Published November 25, 2024

Angiodynamics Auryon Laser System Recall: Potential procedural delays during use

Angiodynamics recalls Auryon Laser System 100-120 VAC model EXM001 due to potential procedural delays during use. Affected units have specific product numbers and serial codes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0770-2025Medical device Angiodynamics ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmAngiodynamics, Inc.603 Queensbury Ave · Queensbury, NY 12804-7619

✎ GovInfoNow plain-language explainer

Angiodynamics is recalling its Auryon Laser System 100-120 VAC model EXM001 because it may not advance to the Activation (Ready) mode during use, causing procedural delays. This could affect medical procedures requiring precise timing. Read more at govinfonow.com/recall/53398-angiodynamics-auryon-laser-system-recall-potential-procedural-delays-during-use.

Source Summary by GovInfoNow · govinfonow.com/recall/53398-angiodynamics-auryon-laser-system-recall-potential-procedural-delays-during-use · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0770-2025

Cite this page

“Angiodynamics Auryon Laser System Recall: Potential procedural delays during use.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53398-angiodynamics-auryon-laser-system-recall-potential-procedural-delays-during-use. Based on FDA recall #Z-0770-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0770-2025%22&limit=1).

Angiodynamics, Inc. recalled the AURYON LASER SYSTEM 100-120 VAC on Nov. 25, 2024, due to a potential for procedural delays or interruptions during use, according to the FDA. The recall affects model EXM001 units distributed nationwide.

How to tell if you have it

Brand: Angiodynamics
Product: AURYON LASER SYSTEM 100-120 VAC
Model Number: EXM001
Product Number: EXM-2001-1100
Quantity: 138 units

The hazard

The Auryon Atherectomy System may not advance to the Activation (Ready) mode, according to the FDA. This defect can cause procedural delays or interruptions during use.

Context

GovInfoNow's records show Angiodynamics, Inc. has had 18 other recalls since June 5, 2017. Recent brand recalls include a Soft-Vu Angiographic Catheter recall on March 3, 2026, and an IsoLoc Prostate Balloon Kit recall on Feb. 4, 2025. Other recent recalls of similar products include a Boston Scientific LUX-Dx Cardiac Monitor System recall (Aug. 6, 2026), a Repligen Maverick Measurement Module Spectrometer recall (Dec. 10, 2025), and a Datex-Ohmeda Aisys Anesthesia System recall (July 30, 2026).

How to tell if you have this one

Check for product number EXM-2001-1100 and model number EXM001. Serial numbers start with EXM followed by three digits.

Brand
Angiodynamics
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify your product has model number EXM001 and product number EXM-2001-1100.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 28 states.

FDA distribution: “US Nationwide distribution to the states of AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NY, OH, PA, RI, TN, TX, VA, WA, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Mississippi, Missouri, New Jersey, New Mexico, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 44 days after the firm started it.

Nov 25, 2024Firm started the recall
Dec 27, 2024FDA classified it Class II
Jan 8, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have this product?

The recall does not require immediate action. Check your product details to confirm if it is affected.

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Link to this recall

<a href="https://govinfonow.com/recall/53398-angiodynamics-auryon-laser-system-recall-potential-procedural-delays-during-use">Angiodynamics Auryon Laser System Recall: Potential procedural delays during use (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0770-2025 (November 25, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0770-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.