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U.S. Department of Health and Human Services

Class 2 Device Recall Nerivio Infinity

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 Class 2 Device Recall Nerivio Infinitysee related information
Date Initiated by FirmMarch 23, 2026
Date PostedJuly 31, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2855-2026
Recall Event ID 99307
510(K)NumberK250405 
Product Classification Distal transcutaneous electrical stimulator for treatment of acute migraine - Product Code QGT
ProductNerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Code Information 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.
FEI Number 3015379717
Recalling Firm/
Manufacturer		 THERANICA BIOELECTRONICS LTD
Poleg Industrial Park
45, Ha-Melakha
Netanya Israel
Manufacturer Reason
for Recall		Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
FDA Determined
Cause 2		Component design/selection
ActionFirm 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 Commerce11,886 units
DistributionThe 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = QGT
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