AngioDynamics NanoKnife Disposable Probes Recalled for Programming Issue
AngioDynamics is recalling 37 NanoKnife Disposable Single Electrode Probes (Lot 5577754) due to a RFID programming issue that prevents the devices from being recognized by the NanoKnife generator.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II medical device recall with a functional defect (RFID programming failure) preventing device operation. No injuries, illnesses, or hospitalizations have been reported. The device is non-functional rather than creating a direct patient safety hazard.
Plain-English summary
AngioDynamics, Inc. is recalling the NanoKnife Disposable Single Electrode Probes, 15 cm Irreversible Electroporation (IRE) device with RFID activation (Catalog No. 20400103). The recall affects 37 units from lot 5577754.
A programming issue affected the RFID function in this lot, preventing the probes from being recognized by the NanoKnife generator. As a result, the devices cannot be activated or used as intended.
The affected devices were internationally distributed to Australia, Germany, Denmark, France, and Thailand.
Healthcare facilities and providers that received these devices should stop using the affected probes and contact AngioDynamics for replacement or return instructions.
The recalled product
- Product
- AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- Affected units
- 37
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- lot 5577754
Distribution
Distribution scope not specified by the agency.
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