NanoKnife recallZ-1381-2023 · Angiodynamics, Inc. · initiated Mar 2, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Angiodynamics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Under Investigation by firm
What the company is doing
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
Recall details
- Recall number
- Z-1381-2023
- Status
- Open, Classified
- Initiated by the company
- Mar 2, 2023
- Posted by the FDA
- Apr 12, 2023
- Recalling firm
- Angiodynamics, Inc.
- Quantity
- 10 boxes( 5 probes/box)
- Product code
- OAB
- FDA submissions
- K183385
- Distribution
- US Nationwide Distribution: CA,CO, FL, IA, NY, OH
Product description
NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110
Code information (models, lots, serial numbers)
UDI-DI: 15051684029643 Lot Number: 5762110
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NanoKnife H787204001110Angiodynamics, Inc. · Low energy direct current thermal ablation system1 recall0 reports
Product lines
Other devices under the same FDA submission
4 devices cleared under K183385 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- NanoKnife 20400107Angiodynamics, Inc. · Low energy direct current thermal ablation system10 reports
- NanoKnife 20300301USAngiodynamics, Inc. · Low energy direct current thermal ablation system1 death8 reports
- NanoKnife 20400111Angiodynamics, Inc. · Low energy direct current thermal ablation system4 reports
- NanoKnife 20400109Angiodynamics, Inc. · Low energy direct current thermal ablation system3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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