FDAFDA recall Z-2855-2026 · Aug 12, 2026
THERANICA BIOELECTRONICS LTD: Nerivio Infinity recall
Recall found
Product
Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Reason for recall
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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 units
- 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
- Recalling firm
- THERANICA BIOELECTRONICS LTD, Netanya
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-03-23
Source: openFDA enforcement record Z-2855-2026 · search recall number Z-2855-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.