CLASS II Device recall · Reported 13 Oct 2021 · FDA Enforcement Report

NanoKnife Disposable Single Electrode Probes recalled by Angiodynamics

Angiodynamics is recalling NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device. The recall was initiated on 24 Apr 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codeslot 5577754

Quantity recalled37

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0073-2022
FDA event ID: 88679
Recalling firm: Angiodynamics, Queensbury, NY
Classification: Class II
Status: Terminated
Recall initiated: 24 Apr 2020
FDA classified: 7 Oct 2021
Reported: 13 Oct 2021
Type: Voluntary: Firm initiated
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

24 Apr 2020	Recall initiated by company
7 Oct 2021	Classified by FDA	+531 days
13 Oct 2021	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103

Where it was distributed

Internationally distribution to the countries of Australia, Germany, Denmark, France, and Thailand.

Questions about this recall

Why was it recalled?

Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator.

Which lots are affected?

lot 5577754

Where was it sold?

Internationally distribution to the countries of Australia, Germany, Denmark, France, and Thailand.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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