FDA Medical devices recall ·
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001… recall
- Recall number
- Z-0770-2025
- Date
- (initiated November 25, 2024)
- Company / brand
- Angiodynamics, Inc.
603 Queensbury Ave, Queensbury, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 138 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Product Number: EXM-2001-1100, Model Number: EXM001. UDI-DI: 07290017590110, Serial Number: EXM XXX.
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: Arkansas Arizona California Colorado Connecticut Florida Georgia Illinois Indiana Kentucky Louisiana Maryland Michigan Minnesota Missouri Mississippi North Carolina New Jersey New Mexico New York Ohio Pennsylvania Rhode Island Tennessee Texas Virginia Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0770-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.