PATH: Medical Device Recall in 2023 - (Recall #: Z-0402-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2

Product Classification:

Class II

Date Initiated: September 26, 2023

Date Posted: December 6, 2023

Recall Number: Z-0402-2024

Event ID: 93275

Reason for Recall:

Affected lots of product may experience technical distortions to a greater extent than expected.

Status: Ongoing

Product Quantity: 28 units

Code Information:

UDI-DI: 04260223145377; Serial Numbers: 290402-290403, 290405-290408, 290422-290433, 290435-290443, 290446

Distribution Pattern:

US States: FL, MO, OH, WI

Voluntary or Mandated:

Voluntary: Firm initiated