# FDA recall Z-0194-2024

> **Olympus Corporation of the Americas** · Class I · device recall initiated 2023-10-12.

## Product

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190

## Reason for recall

There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

## Distribution

US Nationwide distribution

## Key facts

- **Recall number:** Z-0194-2024
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-12
- **Report date:** 2023-11-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0194-2024

## Citation

> AI Analytics. FDA recall Z-0194-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0194-2024. Source: US FDA. Licensed CC0.

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