Drug & Device Safety Atlas

FDA recall record · openFDA

AURIS HEALTH INC

7 FDA recalls on record (2023–2026) — 7 device. 7 still ongoing.

0
Class I (most serious)
7
Class II
0
Class III
7
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view. 3
Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cau 2
Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient- 1
Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscope 1

Recalls

MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-00000 Class II 2026-01-21 MONARCH Bronchoscope. Model Number: MBR-000211-B Class II 2025-10-18 Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, M Class II 2024-08-02 Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB Class II 2024-08-02 Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w Class II 2023-10-18 Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w Class II 2023-10-18 Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w Class II 2023-10-18

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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