---
title: "Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Versi... — FDA record Z-2855-2026 | Is It on Recall"
description: "Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor."
url: https://isitonrecall.com/recall/fda-device-z-2855-2026-nerivio-infinity-model-catalog-number-fgd000100-software-version-fw-version-4-1-2-0-app-version-7-28/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11 — FDA record Z-2855-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 23, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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.
- **Classification**: Class II
- **Recalling firm**: THERANICA BIOELECTRONICS LTD
- **Quantity**: 11,886 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2855-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2855-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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. |

Match all identifying details in the current notice. A brand name alone is not enough.

## 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

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Aug 12, 2026
- **Recall initiation date**: Mar 23, 2026
- **Center classification date**: Jul 31, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2855-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [THERANICA BIOELECTRONICS LTD records](https://isitonrecall.com/brand/theranica-bioelectronics-ltd/)