CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report
Nerivio Infinity recalled by Theranica Bioelectronics
Theranica Bioelectronics is recalling Nerivio Infinity. The recall was initiated on 23 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2855-2026
- FDA event ID
- 99307
- Recalling firm
- Theranica Bioelectronics, Netanya
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Mar 2026
- FDA classified
- 31 Jul 2026
- Reported
- 12 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 23 Mar 2026 | Recall initiated by company | |
| 31 Jul 2026 | Classified by FDA | +130 days |
| 12 Aug 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Where it was distributed
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
Questions about this recall
Is Nerivio Infinity recalled?
Yes. Theranica Bioelectronics recalled Nerivio Infinity on 23 Mar 2026. The recall is Class II and its status is Ongoing. Recall number Z-2855-2026.
Why was it recalled?
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
Which lots are affected?
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.
Where was it sold?
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 should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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