Nerivio Infinity. Model/Catalog Number: FGD000100 recallZ-2855-2026 · Theranica Bioelectronics Ltd · initiated Mar 23, 2026
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 Theranica Bioelectronics Ltd 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
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
FDA root cause category: Component design/selection
What the company is doing
Firm issued a stop ship of product from distributors starting March 22, 2026 after learning of the reported event. These devices were released from hold on 4/30/2026, after the device firmware update was released on 4/19/26. Starting May 13, 2026, customers received in-app messaging which ensure that all affected users receive instructions regarding the required corrective action. Users were prompted to perform a software update affecting both the mobile application used to control the device and the device firmware. The firmware update permanently disables the device upon detection of an overheating event. The software update provides an enhanced warning mechanism if it detects a device malfunction.
Recall details
- Recall number
- Z-2855-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 23, 2026
- Posted by the FDA
- Jul 31, 2026
- Recalling firm
- Theranica Bioelectronics Ltd
- Quantity
- 11,886 units
- Product code
- QGT
- FDA submissions
- K250405
- Distribution
- The product's entry point to the US is a 3PL warehouse from which it is being shipped to DME distributors or specialty pharmacy who perform the shipment to the end-user
Product description
Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Code information (models, lots, serial numbers)
Model/Catalog Number: FGD000100. UDI: 01072900175781181125120221NI2544-0300673 Software Version: FW Version 4.1.2.0, App version 7.28.0.11 GTIN: 7290017578118. Serial Number: NI2544-0300673.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Nerivio Infinity FGD000100Theranica Bio-Electronics Ltd. · Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine1 recall0 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.
How recalls are matched to devices · Editorial policy · Report an error on this page