Recall archive / FDA device enforcement
Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11 — FDA record Z-2855-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 23, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
- Reason
- Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
- Classification
- Class II
- Recalling firm
- THERANICA BIOELECTRONICS LTD
- Quantity
- 11,886 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2855-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
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
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Aug 12, 2026
- Recall initiation date
- Mar 23, 2026
- Center classification date
- Jul 31, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.