# FDA recall Z-0543-2026

> **Auris Health, Inc** · Class II · device recall initiated 2025-10-18.

## Product

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.

## 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.

## Key facts

- **Recall number:** Z-0543-2026
- **Recalling firm:** Auris Health, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-18
- **Report date:** 2025-11-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Clara, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0543-2026

## Citation

> AI Analytics. FDA recall Z-0543-2026. Retrieved 2026-09-07 from https://api.ai-analytics.org/recall/Z-0543-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*