THERANICA BIOELECTRONICS LTD Nerivio Infinity Recall
Announced 2026-08-12 · FDA
Theranica Bioelectronics Ltd is recalling Nerivio Infinity, model FGD000100, due to a potential battery thermal runaway during charging, which could generate smoke and an odor. Approximately 11,886 units were distributed through a 3PL warehouse to DME distributors or specialty pharmacies that ship to end users. The recall is being led by the FDA.
| Brand | THERANICA BIOELECTRONICS LTD |
|---|---|
| Product | Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11 |
| Reason | Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor. |
| Severity | moderate |
| Units affected | 11886 |
| 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 |
| Agency | FDA |
| Recall / campaign no. | 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. |
WHAT YOU SHOULD DO
- Stop using the device and disconnect it from charging immediately.
- Contact Theranica Bioelectronics or the retailer/distributor for instructions on return, replacement, or refund.
- If you own an affected unit, have the model and serial number ready when you contact support.
- Monitor for any signs of overheating, smoke, or odor and seek medical attention if symptoms occur.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.