The Recall Desk
HighFDA (Devices)·Z-0052-2025·Announced 2024-10-16

Monarch Platform Urology Device Recalled for Power Cord Electrical Hazard

Auris Health is recalling Monarch Platform (Urology) devices due to strain relief defects in power cords that may cause electrical short and potential shock to operating room staff.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving a risk-of-harm product (electrical shock hazard) with no reported injuries. Per the severity rubric, this meets the criterion for score 3 (High): 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Auris Health Inc. is recalling the Monarch Platform (Urology), models REF MON-000007 and MON-000007-RFB. Four units have been distributed worldwide, including throughout the United States and Canada.

The affected devices contain a strain relief defect in cart and tower power cords (part numbers 304-003613-00 and 304-003607-00) that may cause an electrical short circuit. This defect may lead to system shutdown during procedures, which can result in prolonged procedures or case conversion. If operating room staff touch exposed wires or conductive fluids in contact with exposed wires, there is a risk of electrical shock.

No illnesses or injuries have been reported in connection with this defect. Affected healthcare facilities and practitioners should discontinue use of the recalled units and contact Auris Health Inc. for repair, replacement, or further instructions.

The recalled product

Product
Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
Manufacturer
AURIS HEALTH INC
Category
Medical Device — Endoscopy/Surgical
Hazard
Affected units
4

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Cart Power Cord 20' 14AWG BLK
  • PN 304-003613-00. Tower Power Cord 20' 14AWG BLK
  • PN 304-003607-00. REF/UDI-DI/Serial Numbers: MON-000007/+B634MON0000070/120059
  • 120133
  • 210002
  • MON-000007-RFB/10810068810889/210001.

Distribution

Distributed nationwide across the United States.

The notice also names 40 states specifically:

Part of a larger recall action

This product is one of 2 recalled by AURIS HEALTH INC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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