DeviceSignal · Recall classified
THERANICA BIOELECTRONICS LTD
FDA classified a device recall on 2026-07-31 · Class II · Z-2855-2026
EventRecall classified
Effective2026-07-31
ClassificationClass II
On 2026-07-31 the FDA classified a device recall from THERANICA BIOELECTRONICS LTD as Class II. Product: Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version…. Recall Z-2855-2026. The firm initiated it on 2026-03-23. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2855-2026
- Classification
- Class II
- Classified on
- 2026-07-31
- Initiated on
- 2026-03-23
- Firm
- THERANICA BIOELECTRONICS LTD
- Reason
- Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
- Product
- Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2855-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
34f010b7fb14e88a4a0f476663ed00cd7183e770751ba7fb22e20db4e6aaf8e6- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)