- Recalling firm
- THERANICA BIOELECTRONICS LTD
- Reason for recall
- Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
- Affected products (lot / model / serial)
- 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.
- Units affected
- 11,886 units
- 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
- Firm location
- Netanya, Israel
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2855-2026
- Recall initiated
- March 23, 2026
- FDA classification date
- July 31, 2026
- FDA report date
- August 12, 2026
- FDA event ID
- 99307
- Last updated on HTM Vibe
- August 18, 2026