Z-1381-2023Class II

NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue...

Name: Z-1381-2023 NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue...
Creator: Angiodynamics, Inc.
Published: 2023-03-02
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2023-03-02 / Open, Classified

FDA source

Angiodynamics, Inc. began a recall of NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110 on 2023-03-02. FDA classified it as Class II and gives the reason as "Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in procedure". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1381-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-02
Posted: 2023-04-12
Recalling firm: Boston Scientific Corporation
Product: NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110
Product code: OAB Low Energy Direct Current Thermal Ablation System
Reason for recall: Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in procedure
FDA root cause: Under Investigation by firm
Action: AngioDynamics issued Urgent Medical Device Recall Letter on March 2, 2023 via Federal Express. Letter states reason for recall health risk and action to take: IMMEDIATELY Stop using the product subject to recall. Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location. Segregate this product in a secure location for return to AngioDynamics, Inc. Forward a copy of this recall notification to all sites to which you have distributed affected product. 2. ComplFx Reply Verification Tracking Form: Attn: NK Probe 5-Pack Recall Coordinator Fax number 1-855-273-0519 3. Package and Return the Recalled Product. Package any product that is being returned in an appropriate shipping box. Write the RMA number on the RMA/Address label (provided on the Recall Verification Tracking Form) and affix the label to the outside of the shipping box. Seal the box and return to: AngioDynamics, Inc. 24 Native Drive Queensbury, NY 12804 Attn: NK Probe 5-Pack Recall Coordinator
Quantity in commerce: 10 boxes( 5 probes/box)
Distribution: US Nationwide Distribution: CA,CO, FL, IA, NY, OH
Product codes and lots: UDI-DI: 15051684029643 Lot Number: 5762110

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1381-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1381-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12

Product code OAB

K183385Class IINanoKnife SystemAngiodynamics / cleared 2019-06-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)