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FDA · Medical devices ·

Nerivio Infinity recall

THERANICA BIOELECTRONICS LTD recalled Nerivio Infinity on August 12, 2026 because of potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor. It was sold in The product's entry point to the US is a 3PL warehouse from which it is being shipped to….

Why it was recalled

Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.

What's recalled

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

Quantity: 11,886 units

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
THERANICA BIOELECTRONICS LTD, Netanya
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
The product's entry point to the US is a 3PL warehouse from which it is being shipped to…
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
Status
Ongoing
Recall number
Z-2855-2026
Source
U.S. Food and Drug Administration

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