MONARCH Bronchoscope. Model Number: MBR-000211-B
Reported: November 26, 2025 Initiated: October 18, 2025 #Z-0543-2026
Product Description
MONARCH Bronchoscope. Model Number: MBR-000211-B
Reason for Recall
Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
Details
- Recalling Firm
- Auris Health, Inc
- Units Affected
- 1,477 units
- Distribution
- Nationwide distribution to AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, MA, MI, MS, MT, NC, NE, NJ, NM, NY, OH, OR, PA, SC, SD, TN, VA, VT, WA, WV.
- Location
- Santa Clara, CA
Frequently Asked Questions
What product was recalled? ▼
MONARCH Bronchoscope. Model Number: MBR-000211-B. Recalled by Auris Health, Inc. Units affected: 1,477 units.
Why was this product recalled? ▼
Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 26, 2025. Severity: Moderate. Recall number: Z-0543-2026.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11