Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0 recall (THERANICA BIOELECTRONICS LTD)
Medical deviceClass IIOngoing
Summary: THERANICA BIOELECTRONICS LTD is recalling 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.
What is being recalled
Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Why
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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
How to tell if yours is affected
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.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2855-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 23, 2026 |
| Reported | August 12, 2026 |
| Company | THERANICA BIOELECTRONICS LTD |
| Company location | Netanya, Israel |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 11,886 units |
More recalls from THERANICA BIOELECTRONICS LTD · all medical device recalls · recalls from March 2026