Z-2855-2026 Class II Ongoing
FDA device recall Z-2855-2026 was initiated by THERANICA BIOELECTRONICS LTD on March 23, 2026 and is designated Class II. Reason for recall: Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor. The recall status is ongoing. Affected quantity: 11,886 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2026
- Initiation Date
- March 23, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,886 units
Product Description
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.
Distribution Pattern
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
Code Information
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.