Angiodynamics, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0770-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 25, 2024

Date Posted: January 8, 2025

Recall Number: Z-0770-2025

Event ID: 95640

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.

Status: Ongoing

Product Quantity: 138 units

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated