The Recall Desk
ModerateFDA (Devices)·Z-1381-2023·Announced 2023-04-19

NanoKnife Surgical Probes Recalled Due to RFID Programming Error

Angiodynamics recalls NanoKnife 5-Probe Procedure Packs due to a programming error affecting RFID function. The probes may not be recognized by the NanoKnife generator, potentially delaying surgical procedures.

What this means for you

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 recall with no reported illnesses or injuries. The hazard is a programming defect causing operational delay rather than a direct patient safety threat.

Plain-English summary

Angiodynamics, Inc. is recalling NanoKnife 5-Probe Procedure Packs (Catalog Number 20400111, Lot Number 5762110) used for surgical ablation of soft tissue. The recall involves 10 boxes containing 5 probes each (50 probes total) distributed across the United States.

The recalled probes were not programmed in accordance with manufacturer specifications. Specifically, a programming error affects the RFID communication function, preventing the probes from being recognized by the NanoKnife generator. This defect causes delays in surgical procedures.

The recalled lot was distributed nationwide, with documented sales in California, Colorado, Florida, Iowa, New York, and Ohio. No illnesses or injuries have been reported in association with this defect.

The recalled product

Product
NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110
Manufacturer
Angiodynamics, Inc.
Hazard
  • programming-defect
  • rfid-failure

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)

  • UDI-DI: 15051684029643 Lot Number: 5762110

Distribution

Distributed nationwide across the United States.