Is THERANICA BIOELECTRONICS LTD recalled?

Yes — a recall has been published. Reason: Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.

TemporaryFDAOngoing

Can cause harm that is usually temporary.

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

Check the device or its packaging 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 2026This is the date the recall was announced. A company may have started it weeks earlier.
Recall began: 23 March 2026

Source: FDA record Z-2855-2026 · retrieved 31 July 2026

Read the official notice

Every recall is shown word for word from the FDA and USDA, with a link to the source.