RegWardenFDA facility compliance records
Company

Auris Health, Inc.

5 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2019: 1 recalls; 2023: 1 recalls; 2024: 1 recalls; 2025: 1 recalls; 2026: 1 recalls201720181201920202021202212023120241202512026
  • Recalls (5)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2026-01-21
    Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may …
  • Class IIOngoing2025-10-18
    Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
  • Class IIOngoing2024-08-02
    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…
  • Class IIOngoing2023-10-18
    Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
  • Class IITerminated2019-04-19
    Reports of aspirating biopsy needle breakage

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Auris Health, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10057462-auris-health-inc/

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