AURIS HEALTH INC
FDA Regulatory Profile
AURIS HEALTH INC has 8 FDA recalls, 4 inspections, 5 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-1383-2026 · Class II · Jan 21, 2026
- Latest inspection
- Feb 7, 2020 · NAI
- Latest 510(k)
- Jul 25, 2026
Part of the Johnson Johnson corporate family.
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 8 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 5 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 4 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1383-2026 | Class II | MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006… | Jan 21, 2026 |
| Z-0543-2026 | Class II | MONARCH Bronchoscope. Model Number: MBR-000211-B | Oct 18, 2025 |
| Z-0052-2025 | Class II | Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB | Aug 2, 2024 |
| Z-0051-2025 | Class II | Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform… | Aug 2, 2024 |
| Z-0449-2024 | Class II | Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w | Oct 18, 2023 |
| Z-0450-2024 | Class II | Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w | Oct 18, 2023 |
| Z-0448-2024 | Class II | Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w | Oct 18, 2023 |
| Z-0025-2020 | Class II | Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120 | Apr 19, 2019 |
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.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260382 | MONARCH Platform (MON-000008) | Jul 25, 2026 |
| K243219 | MONARCH Platform (MON-000008) | Jan 23, 2025 |
| K213334 | Monarch Platform, Urology | Apr 29, 2022 |
| K211493 | Monarch Platform | Jul 9, 2021 |
| K193534 | Monarch Platform | Apr 15, 2020 |