Monarch Platform — Class II medical device recall Z-0052-2025
Ongoing recall by AURIS HEALTH INC, reported 2024-10-16, distributed nationwide. Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords th
| Recall number | Z-0052-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AURIS HEALTH INC, Redwood City, CA, United States |
| Recall initiated | 2024-08-02 |
| Classified | 2024-10-10 |
| Reported by FDA | 2024-10-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 4 |
| UPC / GTIN / UDI-DI | 10810068810889 |
| Serial numbers | 120133, 210002 |
| Model numbers | MON-000007, MON-000007-RFB |
Product
Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
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 prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.
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-0052-2025. 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.