Class III — Diversatek Healthcare
| Recalling firm | DIVERSATEK HEALTHCARE |
|---|---|
| Registered facility | DIVERSATEK HEALTHCARE INC. (the firm's only registered facility) |
| Classification | Class III |
| Status | Ongoing |
| Reason | GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. |
| Product | ZVU Functional GI Software, REF: ZVU-3 |
| Quantity | 20 |
| Distribution | worldwide - US Nationwide distribution in the states of NJ, MN, TN, WA, KY, OR, FL, GA, NY, TX, CO, KS and the countries of Japan, Saudi Arabia. |
| Initiated | 2023-07-25 |
| Classified | 2023-09-07 |
| Recall number | Z-2521-2023 |
| 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 III recall — Diversatek Healthcare (Z-2521-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92854/
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