NeuroSync, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2114-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class II

Date Initiated: September 19, 2023

Date Posted: July 23, 2025

Recall Number: Z-2114-2025

Event ID: 97014

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.

Status: Ongoing

Product Quantity: 27 units

Code Information:

Model No X02. UDI-DI: 00868096000300. Serial Numbers: PA7D50NGF4020311G (Lot P-10114-13), PA7D50NGF4020191G (Lot P-10114-13), PA7D40NGEA080237G (Lot P-10114-12) Software Revisions: Software version uniform across all affected devices

Distribution Pattern:

United States Nationwide distribution in the states of New York (NY), Texas (TX), and Georgia (GA).

Voluntary or Mandated:

Voluntary: Firm initiated