FDAClass II · Medical device · Recall Z-2855-2026 · Recalled August 12, 2026

Nerivio Infinity recall — THERANICA BIOELECTRONICS LTD

Agency report date: August 12, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Nerivio Infinity
Company / brand: THERANICA BIOELECTRONICS
Lot / serial / date codes: 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.
Distribution: 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

Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

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

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Nerivio Infinity

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2855-2026
Brand: THERANICA BIOELECTRONICS
Classification: Class II
Units affected: 11,886 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Nerivio Infinity

Companies & origin

Recalling firm location: Netanya, Israel
Firm address: Poleg Industrial Park, 45, Ha-Melakha, N/A

Identifying details (verbatim from the notice)

Product 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.
Distribution: 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
Firm notified the public via: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
FDA event ID: 99307
Recall initiated: March 23, 2026
FDA classified: July 31, 2026
FDA report date: August 12, 2026

Verify with the official sources:

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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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved September 7, 2026 at 6:00 AM UTC.

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