THERANICA BIOELECTRONICS recalls

Recall found. THERANICA BIOELECTRONICS is named in FDA Class II recall Z-2855-2026 covering Nerivio Infinity. Hazard: Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor. Identifying details: 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.. Status: Ongoing.

Models with recalls

Nerivio Infinity (1)

All THERANICA BIOELECTRONICS recalls

FDA Class II · Medical device · August 12, 2026

Nerivio Infinity recall — THERANICA BIOELECTRONICS LTD

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

Official ID Z-2855-2026 · Official record ↗

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CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Compiled from official public-domain government data. Last checked September 7, 2026 at 6:00 AM UTC.