THERANICA BIOELECTRONICS LTD recalls Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0

Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.

Firm issued a stop ship of product from distributors starting March 22, 2026 after learning of the reported event. These devices were released from hold on 4/30/2026, after the device firmware update was released on 4/19/26. Starting May 13, 2026, customers received in-app messaging which ensure that all affected users receive instructions regarding the required corrective action. Users were prompted to perform a software update affecting both the mobile application used to control the device and the device firmware. The firmware update permanently disables the device upon detection of an overheating event. The software update provides an enhanced warning mechanism if it detects a device malfunction.

• FDA enforcement recordOfficial FDA database entry for Z-2855-2026
• FDA 510(k) clearance · K250405The device's official FDA premarket clearance record
• FDA device classification · QGTOfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.5899The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find THERANICA BIOELECTRONICS LTDSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.