The Recall Desk
ModerateFDA (Devices)·Z-2114-2025·Announced 2025-07-23

NeuroSync EYE-SYNC Eye-Tracking Headsets Recalled Due to Inoperability

NeuroSync recalled 27 EYE-SYNC eye-tracking headset units in New York, Texas, and Georgia because the devices became inoperable after support for the embedded Pico 2 platform ended August 31, 2023, and cannot be repaired.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II medical device recall with no reported illnesses or injuries. The devices became inoperable due to platform discontinuation, rendering them non-functional rather than posing an active safety hazard. This qualifies as a voluntary precautionary recall.

Plain-English summary

NeuroSync, Inc. is recalling 27 units of the NeuroSync EYE-SYNC eye-tracking headset system. The EYE-SYNC is a medical device designed to record, measure, and analyze eye movements in support of diagnosing concussion and mild traumatic brain injury (mTBI). 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.

The recalled devices became inoperable due to eye-syncing issues. The manufacturer cannot repair the affected units because support for the Pico 2 platform was discontinued and is no longer available as of August 31, 2023.

The 27 affected units were distributed nationwide to facilities in New York, Texas, and Georgia. The recalled units have Model No. X02 and UDI-DI 00868096000300, with specific serial numbers and lot codes identified in the FDA recall notice.

Facilities with affected units should discontinue use immediately. Contact NeuroSync, Inc. for instructions regarding return, replacement, or refund. Refer to FDA recall number Z-2114-2025 for complete details including specific serial numbers and lot information.

The recalled product

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 analyz
Manufacturer
NeuroSync, Inc.
Category
Medical Device — Diagnostic / Eye-Tracking System
Hazard
  • inoperability
  • software-discontinuation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • PA7D50NGF4020191G (Lot P-10114-13)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category