⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

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

Medical DevicesSource: FDA (device) · Date: 2026-08-12

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
THERANICA BIOELECTRONICS LTD
Product
Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Reason / hazard
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
Classification
Class II
Status
Ongoing
Distribution / sold at
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
Recall initiated
2026-03-23
Code info
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.
Product quantity
11,886 units
Voluntary mandated
Voluntary: Firm initiated
City
Netanya
Country
Israel
Event id
99307
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