Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2501-2025 — Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)

U.S. FDA — Device Enforcement · Taiwan · 2023-10-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2501-2025
Date of alert
2023-10-04
Country / jurisdiction
Taiwan
Risk level
Class II
Risk type
recall
Brand
Visgeneer, Inc.
Product category
device
Product type
Devices
Reported risk: Due to products distributed without premarket clearance or approvals.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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