Food, drugs, devices › Angiodynamics, Inc.
Device recall: AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single
FDA enforcement event 88679 is a device recall by Angiodynamics, Inc. of Queensbury, NY, initiated 24 Apr 2020 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. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 20 Sep 2022. 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
"Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator."
Distribution
"Internationally distribution to the countries of Australia, Germany, Denmark, France, and Thailand."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0073-2022 | AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103 | 37 | Class II | Terminated | 13 Oct 2021 |
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: "Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator."
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: "Internationally distribution to the countries of Australia, Germany, Denmark, France, and Thailand."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 Sep 2022. "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.