Nerivio Infinity — Class II medical device recall Z-2855-2026
Ongoing recall by THERANICA BIOELECTRONICS LTD, reported 2026-08-12. Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
| Recall number | Z-2855-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | THERANICA BIOELECTRONICS LTD, Netanya, Israel |
| Recall initiated | 2026-03-23 |
| Classified | 2026-07-31 |
| Reported by FDA | 2026-08-12 |
| Quantity | 11,886 units |
| UPC / GTIN / UDI-DI | 07290017578118 |
| Serial numbers | NI2544-0300673 |
| Model numbers | FGD000100 |
Product
Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Reason for recall
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2855-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.