Home / Recalls / Medical Devices
THERANICA BIOELECTRONICS LTD recalls Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Recalled August 12, 2026 · FDA recall Z-2855-2026 · THERANICA BIOELECTRONICS
Hazard
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor. · FDA Class II
Units
11,886 units
Sold at
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
Description
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
Product
Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Manufacturer(s)
THERANICA BIOELECTRONICS LTD
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →