# FDA recall Z-0052-2025

> **AURIS HEALTH INC** · Class II · device recall initiated 2024-08-02.

## 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.

## Distribution

Worldwide - US Nationwide distribution including in the states of MN, FL, NC, AK, NJ, NY, VA, WI, AZ, MS, LA, MI, MA, MT, WV, GA, DE, TX, CA, OH, IN, SC, PA, CT, ND, MO, DC, IL, NE, ID, WA, TN, OR, AL, SD, CO, KY, NM, VT, MD and the countries of Canada.

## Key facts

- **Recall number:** Z-0052-2025
- **Recalling firm:** AURIS HEALTH INC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-02
- **Report date:** 2024-10-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Redwood City, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0052-2025

## Citation

> AI Analytics. FDA recall Z-0052-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0052-2025. Source: US FDA. Licensed CC0.

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