Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2114-2025 — 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

U.S. FDA — Device Enforcement · United States · 2023-09-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2114-2025
Date of alert
2023-09-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
NeuroSync, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00868096000300
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.