AURIS HEALTH INC
AURIS HEALTH INC appears in FDA public data with 8 recalls, 5 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1383-2026, Class II) was initiated on January 21, 2026. Its most recent 510(k) clearance was granted on July 25, 2026.
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 5
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1383-2026 | Class II | MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-0 | January 21, 2026 |
| Z-0543-2026 | Class II | MONARCH Bronchoscope. Model Number: MBR-000211-B | October 18, 2025 |
| Z-0052-2025 | Class II | Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB | August 2, 2024 |
| Z-0051-2025 | Class II | Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy) | August 2, 2024 |
| Z-0448-2024 | Class II | Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w | October 18, 2023 |
| Z-0450-2024 | Class II | Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w | October 18, 2023 |
| Z-0449-2024 | Class II | Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w | October 18, 2023 |
| Z-0025-2020 | Class II | Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120 | April 19, 2019 |