FDA Device recall Z-0770-2025
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001
- FDA Device
- Class II
- ongoing
- Published 2025-01-08
On 2025-01-08 the FDA classified a Class II recall of AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001 by Angiodynamics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0770-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-25 |
| Published | 2025-01-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Angiodynamics |
| Distribution | US |
Product
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Reason
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.
Identifiers
| code_info | Product Number: EXM-2001-1100, Model Number: EXM001. UDI-DI: 07290017590110, Serial Number: EXM XXX. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0770-2025%22
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