THERANICA BIOELECTRONICS LTD recalls Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
Read the official notice →- Date
- 2026-08-12
- Country
- United States
- Brand
- THERANICA BIOELECTRONICS LTD
- Product
- Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
- Classification
- Class II
- Units
- The product's entry point to the US is a 3PL warehouse from which it is being…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
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General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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