Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
FDA Recall Z-2855-2026 · Posted 2026-07-31
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Recalling FirmTHERANICA BIOELECTRONICS LTD
Recall StatusOpen, Classified
Product CodeQGT
Date Initiated2026-03-23
Product Quantity11,886 units
Reason for Recall
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
Firm Action
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.
Root Cause
Component design/selection
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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