CLASS II ONGOING Device recall · Reported 8 Jan 2025 · FDA Enforcement Report

Auryon Laser System 100-120 Vac recalled by Angiodynamics

Angiodynamics is recalling Auryon Laser System 100-120 Vac, distributed nationwide in the US. The recall was initiated on 25 Nov 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Number: EXM-2001-1100, Model Number: EXM001. UDI-DI: 07290017590110, Serial Number: EXM XXX.

Quantity recalled138 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0770-2025
FDA event ID: 95640
Recalling firm: Angiodynamics, Queensbury, NY
Classification: Class II
Status: Ongoing
Recall initiated: 25 Nov 2024
FDA classified: 27 Dec 2024
Reported: 8 Jan 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

25 Nov 2024	Recall initiated by company
27 Dec 2024	Classified by FDA	+32 days
8 Jan 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for 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.

Product as listed by the FDA

AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100

Where it was distributed

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.

Nationwide Arkansas Arizona California Colorado Connecticut Florida Georgia Illinois Indiana Kentucky Louisiana Maryland Michigan Minnesota Missouri Mississippi North Carolina New Jersey New Mexico New York

Questions about this recall

Is Auryon Laser System 100-120 Vac recalled?

Yes. Angiodynamics recalled Auryon Laser System 100-120 Vac on 25 Nov 2024. The recall is Class II and its status is Ongoing. Recall number Z-0770-2025.

Why was it 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.

Which lots are affected?

Product Number: EXM-2001-1100, Model Number: EXM001. UDI-DI: 07290017590110, Serial Number: EXM XXX.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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