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Medical Device

Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11

Recall date: 2026-08-12 · Source: FDA_DEVICE
Brand / Firm
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 for recall
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
Units affected
11,886 units
Description
Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
View official recall notice →