The Recall Desk
HighFDA (Devices)·Z-2855-2026·Announced 2026-08-12

Nerivio Infinity Device Recall Over Battery Thermal Runaway Risk

Theranica is recalling 11,886 Nerivio Infinity devices due to a potential battery thermal-runaway event during charging that may produce smoke and odor.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (battery thermal-runaway during charging) where no injuries have been reported, which corresponds to the High severity criterion for risk-of-harm products without reported injury.

Plain-English summary

Theranica Bioelectronics Ltd is recalling the Nerivio Infinity device, model/catalog number FGD000100, with firmware version 4.1.2.0 and app version 7.28.0.11. A total of 11,886 units are included in the recall.

The recall is being issued because the device's battery may experience a thermal-runaway event during charging, which can result in smoke and odor. No injuries or fatalities have been reported in connection with this issue.

The recalled devices were distributed in the United States through a third-party logistics (3PL) warehouse, which shipped them to durable medical equipment (DME) distributors and specialty pharmacies that then delivered the devices to end-users.

Consumers who have received a Nerivio Infinity device should stop using it immediately and contact Theranica or their healthcare provider for instructions on returning the device and obtaining a replacement if needed.

The recalled product

Product
Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Manufacturer
THERANICA BIOELECTRONICS LTD
Category
Medical Device — Therapeutic Device
Hazard
Affected units
11,886

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • App version 7.28.0.11 GTIN: 7290017578118. Serial Number: NI2544-0300673.

Distribution

Distribution scope not specified by the agency.

Related recalls

Same hazard · thermal runaway

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