Auris Health recalls Monarch Platform urology devices with potential electrical short in power cords, risking shock if exposed. Affected units have specific serial numbers and model codes.
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.
Auris Health is recalling urology devices that may have a strain relief defect in power cords. This defect could cause electrical shorts, leading to system shutdowns or electrical shock if exposed wires touch conductive fluids.
The power cords may develop a strain relief defect, causing electrical shorts. If the system shuts down during a procedure, it could lead to prolonged surgery or case conversion. If exposed wires contact conductive fluids or the user touches them, electrical shock is possible.
Operating room staff using the Monarch Platform urology devices are most at risk. The recall affects specific units with the listed serial numbers and model codes.
Check for the Monarch Platform urology devices with serial numbers starting with MON-000007 and model codes like 304-003613-00 or 304-003607-00. The specific serial numbers listed in the recall include MON-000007/+B634MON0000070/120059, 120133, 210002 and MON-000007-RFB/10810068810889/210001.
Look for serial numbers starting with MON-000007 or MON-000007-RFB as listed in the recall.
Reach out to Auris Health for further guidance on the specific device model and remedy.
The power cords may have a strain relief defect that causes electrical shorts, potentially leading to system shutdowns or electrical shock if exposed wires contact conductive fluids.
Check for serial numbers starting with MON-000007 or MON-000007-RFB, and model codes like 304-003613-00 or 304-003607-00 as listed in the recall.
Contact Auris Health directly for specific instructions on the affected device model and remedy.
We’ve drafted a message you can send Auris Health to request your refund or repair — edit it as you like.
Subject: Recall Z-0052-2025 — Auris Health Auris Health Hello, I own a Auris Health that is covered by recall Z-0052-2025 from Auris Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
