Nerivio Infinity Recall Issued for Battery Issue
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Theranica Bioelectronics Ltd is recalling 11,886 units of Nerivio Infinity devices due to potential battery thermal-runaway events during charging.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 19, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened Theranica Bioelectronics Ltd initiated a voluntary recall of the Nerivio Infinity device after identifying a potential for the battery to have a thermal-runaway event during charging, resulting in smoke and odor.
Which Products Are Affected The recall covers Nerivio Infinity, Model/Catalog Number FGD000100, with Software Version FW Version 4.1.2.0 and App version 7.28.0.11. A total of 11,886 units are affected under recall number Z-2855-2026. The devices were distributed in the United States through a 3PL warehouse to DME distributors and specialty pharmacies.
What You Should Do Consumers with questions should contact the recalling firm for additional guidance on the recall.
Why This Matters The Class II recall addresses a device defect that could lead to smoke and odor during charging.
Source FDA recall Z-2855-2026, report date 20260812.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (888 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 19, 2026.
Frequently Asked Questions
Common questions about this FDA recall.