Theranica Bioelectronics Ltd: Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
- Recalling firm
- 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
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-23
- Status
- Open, Classified
- 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
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/6020c04b-c376-458c-9ab7-4073bbda94cd