FDAHealthMarch 23, 2026
THERANICA BIOELECTRONICS LTD — 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.
Is this relevant to me?
- Geography
- US
- Source agency
- FDA
- Category
- Health
- Published
- March 23, 2026
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
What's affected?
- Product
- Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
- Lot code
- 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.
Additional details
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.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 11,886 units.
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