Official recall notice

FDA DeviceClass IINotable

FDA Recall: Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App versi

Recall date
2026-08-12
FDA class
Class II

Why it was recalled

Hazard

Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.

Product description

Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.

Affected products

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.

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