FDA Medical devices recall ·
Nerivio Infinity recall
- Recall number
- Z-2855-2026
- Date
- (initiated March 23, 2026)
- Company / brand
- Theranica Bioelectronics Ltd
Poleg Industrial Park, Netanya, Israel - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 11,886 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Why was it recalled?
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2855-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.