Skip to content
RecallWatchMedical Device Safety
Class IIOngoingZ-2500-2025

Visgeneer, Inc. recalls Blood Uric Acid Monitoring System Each kit contains 1 meter

Visgeneer, Inc.Hsinchu City, TaiwanReported Sep 10, 2025 · 10 months ago
Legal News Analyst ·

Reason for recall

Due to products distributed without premarket clearance or approvals.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
    6 affected lots
    eB-U0125pcs20232023v1.02025-04-14

What the firm is doing

On 12/04/2023, the firm sent an email titled, "FDA notification about eBuricacid" to its distibutors informing them that Visgeneer has received a notice from FDA that the eBuricacid/Uritouch Blood uric acid monitors are not cleared to be marketed/distributed within the U.S. and is requesting that the products (kits and strips) be delisted from Amazon site as soon as possible. An additional email was sent to distributors on 06/23/2025 and 07/01/2025 as a follow up to the 12/04/2023 email - requesting for information on the quantities of monitors/kits and strips that were removed from Amazon, and instructing the distributor to destroy the stock of affected products on hand and noting that the strips are expired.

DistributionShow details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

More Class II recalls