# FDA recall Z-2501-2025

> **Visgeneer, Inc.** · Class II · device recall initiated 2023-10-04.

## Product

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

## Reason for recall

Due to products distributed without premarket clearance or approvals.

## Distribution

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

## Key facts

- **Recall number:** Z-2501-2025
- **Recalling firm:** Visgeneer, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-04
- **Report date:** 2025-09-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hsinchu City, N/A, Taiwan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2501-2025

## Citation

> AI Analytics. FDA recall Z-2501-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2501-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*