Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11

Check your package for

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.

Why: Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
Distributed: 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
Company: THERANICA BIOELECTRONICS LTD
Announced: 12 August 2026
Recall began: 23 March 2026

Read the official notice

Every recall — food, medication, or medical device — is shown word-for-word from the official FDA or USDA notice, with a link straight to it. Nothing here is summarised, reworded, or filled in. This site is not affiliated with any government agency.