AURIS HEALTH INC
7 federal recalls on file, showing the 2 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for AURIS HEALTH INC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-02-25FDA-DeviceClass IIStop using affected Auris Health MONARCH devices
The MONARCH Platform bronchoscopy device has a software issue that can cause the robotic arm to move unexpectedly. If the application restarts after you select a position but before loading the bronchoscope, the system may reset to the left side even if you selected right, potentially causing the arm to contact the patient or breathing tube.
- 2025-11-26FDA-DeviceClass IIMONARCH Bronchoscope. Model Number: MBR-000211-B
Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
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