INNOVA MEDICAL GROUP, INC.
FDA Regulatory Profile
INNOVA MEDICAL GROUP, INC. has 3 FDA recalls (3 Class I), 3 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- Z-1538-2021 · Class I · Apr 9, 2021
- Latest inspection
- Aug 5, 2022 · NAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 3 (3 Class I) | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 3 | Nov 10, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1538-2021 | Class I | For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid… | Apr 9, 2021 |
| Z-1537-2021 | Class I | COVID-19 Self-Test Kit *** INNOVA *** 7T | Apr 9, 2021 |
| Z-1539-2021 | Class I | COVID-19 Self-Test Kit *** INNOVA *** 3T | Apr 9, 2021 |
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.