NeuroSync EYE-SYNC containing Pico Neo 2 Headsets — Class II medical device recall Z-2114-2025
Ongoing recall by NeuroSync, Inc., reported 2025-07-23, distributed nationwide. Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuation of suppor
| Recall number | Z-2114-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | NeuroSync, Inc., Holliston, MA, United States |
| Recall initiated | 2023-09-19 |
| Classified | 2025-07-11 |
| Reported by FDA | 2025-07-23 |
| Distributed | Nationwide (US) |
| Quantity | 27 units |
| UPC / GTIN / UDI-DI | 00868096000300 |
| Lot numbers | P-10114-12, P-10114-13 |
| Serial numbers | PA7D50NGF4020311G |
| Model numbers | X02 |
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).
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2114-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.