FDA Medical Device Recalls (openFDA)
Angiodynamics, Inc.: AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103
- Recall number
- Z-0073-2022
- Recalling firm
- Angiodynamics, Inc.
- Product
- AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103
- Status
- Terminated
- Initiated
- 2020-04-24
- Posted
- not on file
- Terminated
- 2022-09-20
- Reason
- Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator.
- Root cause
- Software Manufacturing/Software Deployment
- Action
- On April 24, 2020, the firm distributed recall notifications to their consignees, who were all international (non-US). Customers were advised to stop using the recalled product, remove it from inventory, and segregate in a secure location for return. The firm provided further instructions for the return of the product.
- Quantity
- 37
- Distribution
- Internationally distribution to the countries of Australia, Germany, Denmark, France, and Thailand.
- Lot, serial or model codes
- lot 5577754
- 510(k) numbers
- ["K150089"]
- PMA numbers
- not on file
- Product code
- OAB
- Firm FEI
- 1319211
- Firm city
- Queensbury
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28