Z-2855-2026Class II

Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11

Name: Z-2855-2026 Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Creator: Theranica Bioelectronics Ltd
Published: 2026-03-23
License: https://open.fda.gov/license/

Theranica Bio-Electronics Ltd. / initiated 2026-03-23 / Open, Classified / root cause: design

FDA source

THERANICA BIOELECTRONICS LTD began a recall of Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11 on 2026-03-23. FDA classified it as Class II and gives the reason as "Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2855-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-23
Posted: 2026-07-31
Recalling firm: Theranica Bio-Electronics Ltd.
Product: Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Product code: QGT Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
Reason for recall: Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
Root cause tag: design
FDA root cause: Component design/selection
Action: Firm issued a stop ship of product from distributors starting March 22, 2026 after learning of the reported event. These devices were released from hold on 4/30/2026, after the device firmware update was released on 4/19/26. Starting May 13, 2026, customers received in-app messaging which ensure that all affected users receive instructions regarding the required corrective action. Users were prompted to perform a software update affecting both the mobile application used to control the device and the device firmware. The firmware update permanently disables the device upon detection of an overheating event. The software update provides an enhanced warning mechanism if it detects a device malfunction.
Quantity in commerce: 11,886 units
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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2855-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2855-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-07-31

Product code QGT

K250405Class IINerivio; Nerivio InfinityTheranica Bio-Electronics, Ltd. / cleared 2025-05-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)