Class II — Visgeneer, Inc.
| Recalling firm | VISGENEER, INC. |
|---|---|
| Registered facility | VISGENEER, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to products distributed without premarket clearance or approvals. |
| 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) |
| Quantity | 2240 |
| Distribution | Worldwide - U.S. Nationwide distribution in the states of CA and MI. The country of Canada. |
| Initiated | 2023-10-04 |
| Classified | 2025-09-02 |
| Recall number | Z-2500-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Visgeneer, Inc. (Z-2500-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97328/
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