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Nerivio Infinity Battery
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MEDICAL DEVICE RECALLMODERATE

Nerivio Infinity Battery

Theranica recalls Nerivio Infinity over battery thermal-runway risk during charging.

What to do

Stop using the device immediately. Do not charge the device. Contact Theranica Bioelectronics for instructions on returning the device and obtaining a replacement or refund.

Recalled
Listed
Updated
Recall No.
Z-2855-2026
Agency
FDA
Firm
THERANICA BIOELECTRONICS LTD
Recall ID
99307
Status
ONGOING

Recall at a glance

Quantity recalled
11,886 units

Why it was recalled

Theranica Bioelectronics is recalling the Nerivio Infinity migraine treatment device due to a potential thermal-runway event during charging that may produce smoke and odor. The recall affects model FGD000100 with firmware version 4.1.2.0 and app version 7.28.0.11.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

UDI-DI
7290017578118

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Device Defect recalls

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Editorial summary by Recall Canary · summary updated 2026-08-02 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification