Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
FDA device recall Z-2855-2026 · posted 2026-07-31 · Open, Classified
Recall details
- Recalling firm
- THERANICA BIOELECTRONICS LTD
- Reason for recall
- Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- QGT
- Quantity affected
- 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
- Date initiated
- 2026-03-23
- Date posted
- 2026-07-31
- Location
- Netanya, Ha-Melakha, Israel
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Nerivio; Nerivio Infinity (K250405) | Theranica Bio-Electronics, Ltd. | 2025-05-14 |