# FDA recall Z-0770-2025

> **Angiodynamics, Inc.** · Class II · device recall initiated 2024-11-25.

## Product

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

## 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.

## 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.

## Key facts

- **Recall number:** Z-0770-2025
- **Recalling firm:** Angiodynamics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-25
- **Report date:** 2025-01-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Queensbury, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0770-2025

## Citation

> AI Analytics. FDA recall Z-0770-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0770-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*