AURYON LASER SYSTEM 100-120 VAC — Class II medical device recall Z-0770-2025
Ongoing recall by Angiodynamics, Inc., reported 2025-01-08, distributed nationwide. Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon
| Recall number | Z-0770-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Angiodynamics, Inc., Queensbury, NY, United States |
| Recall initiated | 2024-11-25 |
| Classified | 2024-12-27 |
| Reported by FDA | 2025-01-08 |
| Distributed | Nationwide (US) |
| Quantity | 138 units |
| UPC / GTIN / UDI-DI | 07290017590110 |
| Model numbers | EXM001 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0770-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.