Visgeneer, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2501-2025)

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:

Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)

Product Classification:

Class II

Date Initiated: October 4, 2023

Date Posted: September 10, 2025

Recall Number: Z-2501-2025

Event ID: 97328

Reason for Recall:

Due to products distributed without premarket clearance or approvals.

Status: Ongoing

Product Quantity: 2580

Code Information:

Lot Code: Model No: eB-U01 UDI-DI: None. Lot Numbers: All lots manufactured up to Jun. 20, 2022 Serial Numbers: All lots manufactured up to Jun. 20, 2022 Software Revisions: Firmware v1.0 Expiration Dates: Test strips: up to 2023-12-19

Distribution Pattern:

Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated