Food, drugs, devices › Angiodynamics, Inc.
Device recall: AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
FDA enforcement event 95640 is a device recall by Angiodynamics, Inc. of Queensbury, NY, initiated 25 Nov 2024 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Angiodynamics, Inc. has 24 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Angiodynamics, Inc., Queensbury, NY.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0770-2025 | AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100 | 138 units | Class II | Ongoing | 8 Jan 2025 |
Context
Other enforcement events for Angiodynamics, Inc.
All 24 events for Angiodynamics, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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 does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.