Drug recall
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF…
FDA recall event 95336 · Class II · AURIS HEALTH INC
Key facts
| Event ID | 95336 |
|---|---|
| Recall numbers | Z-0051-2025, Z-0052-2025 |
| Recalling firm | AURIS HEALTH INC |
| Product type | Devices |
| Products | Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB., Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to… |
| Initiation date | Aug 2, 2024 |
| Report date | Oct 16, 2024 |
| City | Redwood City |
| State | CA |
| Country | United States |
| FEI number | 3014447948 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: