THERANICA BIOELECTRONICS LTD Nerivio Infinity Recall
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 |
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.
How to identify the recalled item
| Lot / date codes | 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. |
|---|---|
| Lot / date codes | 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. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.