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Class IIOngoing

THERANICA BIOELECTRONICS LTD recalls Nerivio Infinity

Recall date · record updated Aug 12, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
THERANICA BIOELECTRONICS LTD
Reason
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99307…

Products

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

    Codes/lots: 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: 11,886 unitsRecall no. Z-2855-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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