FDA recall, , Moderate risk
THERANICA BIOELECTRONICS Nerivio Infinity
Nerivio Infinity has a potential for a thermal-runway event during charging, resulting in smoke and odor.
Summary by Recall Canary from the FDA notice
What happened
THERANICA BIOELECTRONICS LTD of Netanya, Israel began a recall of Nerivio Infinity on March 23, 2026, due to a potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor. The FDA added the recall to its Enforcement Report on July 31, 2026, and it was in the weekly enforcement report on August 12, 2026. The product is distributed through a 3PL warehouse to DME distributors or specialty pharmacies for shipment to end-users.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Nerivio Infinity
- Model number
- FGD000100
- UDI-DI
- 7290017578118
Recall details
- Company began the recall
- Sold in
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
- Company
- THERANICA BIOELECTRONICS LTDNetanya, Israel
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99307
- Recall number
- Z-2855-2026
- Quantity recalled
- 11,886 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
