Class II
Medical Device Recall: Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
THERANICA BIOELECTRONICS LTD · March 23, 2026
Reason for Recall
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
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
States Affected
OR
Quantity Affected
11,886 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2855-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.