ZVU Functional GI Software — Class III medical device recall Z-2521-2023
Ongoing recall by Diversatek Healthcare, reported 2023-09-13, distributed nationwide. GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
| Recall number | Z-2521-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diversatek Healthcare, Highlands Ranch, CO, United States |
| Recall initiated | 2023-07-25 |
| Classified | 2023-09-07 |
| Reported by FDA | 2023-09-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP, SA |
| Quantity | 20 |
| Reason classes | labeling, software |
| UPC / GTIN / UDI-DI | 00816734022825 |
| Model numbers | ZVU-3 |
Product
ZVU Functional GI Software, REF: ZVU-3
Reason for recall
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
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-2521-2023. 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.