Netanya, Israel
THERANICA BIOELECTRONICS LTD recalls
1 recall recorded since 2018, most recently on 23 March 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 23 March 2026
- Reason
- Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2855-2026
- Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.