FDA Device recall Z-2855-2026
Nerivio Infinity
- FDA Device
- Class II
- ongoing
- Published 2026-08-12
On 2026-08-12 the FDA classified a Class II recall of Nerivio Infinity by Theranica Bioelectronics, citing potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2855-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-23 |
| Published | 2026-08-12 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Theranica Bioelectronics |
| Distribution | n/a |
Product
Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Reason
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
Identifiers
| code_info | Model/Catalog Number: FGD000100. UDI: 01072900175781181125120221NI2544-0300673 Software Version: FW Version 4.1.2.0, Ap…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2855-2026%22
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