THERANICA BIOELECTRONICS LTD recalls Nerivio Infinity.
- Recalling company
- 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
- Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 23, 2026
- Reported
- Aug 12, 2026
- Distribution
- 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
- Status
- Ongoing
- Quantity
- 11,886 units
- Lot / codes
- 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.
- Company location
- Netanya
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2855-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2855-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.