Reported Aug 12, 2026 · Ongoing · Updated Sep 16, 2026
Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Theranica Bioelectronics Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: THERANICA BIOELECTRONICS LTD · Poleg Industrial Park, 45, Ha-Melakha · Netanya
Is this the product you have?
- Nerivio Infinity
- Model/Catalog NumberFGD000100
- Software Version
FW Version 4.1.2.0App version 7.28.0.11
- Lot codes and dates
- Model/Catalog NumberFGD000100
- UDI01072900175781181125120221NI2544-0300673
- Software Version
FW Version 4.1.2.0App version 7.28.0.11
- GTIN7290017578118
- Serial NumberNI2544-0300673
- Amount recalled
- 11,886 units
Why it was recalled
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
This product could cause temporary or reversible health problems — stop using it.
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