Blood Uric Acid Monitoring System Each kit contains 1 meter — Class II medical device recall Z-2500-2025
Ongoing recall by Visgeneer, Inc., reported 2025-09-10, distributed nationwide. Due to products distributed without premarket clearance or approvals.
| Recall number | Z-2500-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Visgeneer, Inc., Hsinchu City, N/A, Taiwan |
| Recall initiated | 2023-10-04 |
| Classified | 2025-09-02 |
| Reported by FDA | 2025-09-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 2,240 |
| UPC / GTIN / UDI-DI | 04712558761116, 04712558761123, 04712558761208 |
| Model numbers | EB-U01 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2500-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.