Class II U.S. Food and Drug Administration

Theranica Bioelectronics Ltd Nerivio Infinity. Model/ recall: Potential for the batter to have a thermal-runway event during charging

Recall published 2 months ago

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

The hazard: Fire or burn hazard

A fire or burn risk is what prompted this recall. Most of these incidents happen while the product is charging or left running unattended.

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

Why it matters: The product can overheat, ignite or cause a burn. Where lithium batteries are involved the failure is fast and very hot, and water does not put it out quickly.

Symptoms and when to call a doctor

Treat a burn by cooling it under running water for about 20 minutes — not with ice, butter or ointment — and cover it loosely with a clean non-fluffy cloth. Get medical help for burns that are larger than the person’s palm, that are deep or white or charred, that involve the face, hands, feet or genitals, or any burn to a baby or young child. If someone has inhaled smoke and is coughing, hoarse or short of breath, call 911.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2855-2026
Published
August 12, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Theranica Bioelectronics Ltd
Product type
Medical devices
Units affected
11,886 units
Made in
Israel
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.
UPC codes
7290017578118

Products covered by this recall

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

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 7290017578118

Model or item number

On the rating label, the box or the instruction sheet.

  • FGD000100. Software Version
  • FGD000100. UDI

Serial number

On the rating plate, often next to the date of manufacture.

  • NI2544-0300673. — 11
  • 886 units

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Fire

Theranica Bioelectronics Ltd — A fire or burn risk is what prompted this recall. Most of these incidents happen while the product is charging or left running unattended.

  1. Stop using it and unplug it from the wall. If it runs on a battery pack, stop charging it.
  2. Check that your smoke alarms work while you are thinking about it, and follow the remedy on this page.
  3. Move it off anything that burns — a bed, a sofa, a carpet, a pile of paper — and away from exits.
  4. Do not leave it charging overnight or while the house is empty while you wait for the remedy.

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • Several recalls now ask you to destroy the item and send a photo as proof. Register the claim before you do that, never after.
  • Return shipping is the company’s cost. If you are asked to pay it, push back.
  • A repair kit is shipped free and is designed to be fitted at home; if you cannot fit it, ask whether they will arrange installation.

Company contact: THERANICA BIOELECTRONICS LTD — Poleg Industrial Park, Netanya

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Theranica Bioelectronics Ltd medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 7290017578118; model number FGD000100. Software Version, FGD000100. UDI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using it and unplug it from the wall. If it runs on a battery pack, stop charging it.

Can I get my money back?

A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.

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