The Recall Desk

Manufacturer

Auris Health, Inc

8 recalls in our database name Auris Health, Inc as the manufacturing or recalling firm.

What the numbers show

Total
8
Critical
0
Severe
0
Most recent
2026-02-25

Of the 8 recalls from Auris Health, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–8 of 8

  • HighFDA (Devices)·Z-1383-2026·2026-02-25

    Bronchoscopy robots recalled over arms that may move toward patient-left

    Auris Health is recalling 173 MONARCH Platform bronchoscopy systems because a software restart can re-initialize the system to patient-left, leading to unanticipated robotic arm positioning.

    Product
    MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0052-2025·2024-10-16

    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.

    Product
    Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0051-2025·2024-10-16

    Endoscopy and Bronchoscopy Systems Power Cord Defect Risk

    Monarch Platform endoscopy and bronchoscopy systems may have defective power cords causing electrical shorts and shock risk if exposed wires are touched, potentially leading to system shutdown.

    Product
    Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0449-2024·2023-12-13

    Monarch Platform Bronchoscope Software Issue Causes Flipped Display

    Auris Health is recalling 110 units of the Monarch Platform bronchoscope due to a software defect that may flip the image display. This inverted view could impact visualization during airway procedures.

    Product
    Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-0450-2024·2023-12-13

    Monarch Platform Bronchoscopy Device Recalled for Software Image Inversion

    AURIS HEALTH INC is recalling approximately 110 units of the Monarch Platform bronchoscopy surgical device due to a software defect that can flip the displayed image during procedures. No injuries have been reported.

    Product
    Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-0448-2024·2023-12-13

    Monarch Platform bronchoscope recalled for potential software image inversion

    AURIS Health is recalling the Monarch Platform virtual bronchoscope due to potential software issues that may flip the displayed surgical image, which could impair visualization during minimally invasive procedures.

    Product
    Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-0025-2020·2019-11-27

    Auris Health Recalls Monarch Aspirating Biopsy Needles Due to Breakage Reports

    Auris Health is recalling 158 Monarch Aspirating Biopsy Needles because of reports of needle breakage. The devices were distributed to 11 states.

    Product
    Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Auris Health (United States)

company in Redwood City, United States

Country
United States
Founded
2007

Official website

Source: Wikidata (Q56585141), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.