Recall Z-2855-2026 ยท QGT Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
THERANICA BIOELECTRONICS LTD
Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
| Date | Jul 31, 2026 (initiated Mar 23, 2026) |
| Status | Open, Classified |
| Reason | Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor. |
| Root cause | Component design/selection |
| 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 o |
| Quantity | 11,886 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K250405 | Nerivio; Nerivio Infinity Theranica Bio-Electronics, Ltd., May 14, 2025 |