Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Summary
The FDA issued a Class II for Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Versio by THERANICA BIOELECTRONICS LTD. Reason: Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor..
Details
Source
Device Recall
External ID
Z-2855-2026
Action Date
2026-08-12
Status
Ongoing
Category
device
Product Description
Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Lot/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.
Quantity Affected: 11,886 units
Reason for Recall
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-23
Company
Netanya
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 400 device-related FDA actions this month.
THERANICA BIOELECTRONICS LTD has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (THERANICA BIOELECTRONICS LTD) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does THERANICA BIOELECTRONICS LTD have FDA actions?
THERANICA BIOELECTRONICS LTD has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2855-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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