Class II — NeuroSync, Inc.
| Recalling firm | NeuroSync, Inc. |
|---|---|
| Registered facility | NEUROSYNC, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuation of support for the Pico 2 platform, which was no longer in production or serviceable as of August 31, 2023. |
| Product | NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and proprietary software, packaged in a portable field case. Eye-tracking headset system is intended for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects. The EYE-SYNC is intended to record, measure, and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI). |
| Quantity | 27 units |
| Distribution | United States Nationwide distribution in the states of New York (NY), Texas (TX), and Georgia (GA). |
| Initiated | 2023-09-19 |
| Classified | 2025-07-11 |
| Recall number | Z-2114-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — NeuroSync, Inc. (Z-2114-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97014/
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