# FDA recall Z-2497-2021

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2021-08-17.

## Product

EVIS EXERA BF-XT160  Bronchofibervideoscope, Model No. BF-XT160

## Reason for recall

A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.

## Distribution

US Nationwide distribution in the states of CA, IL, MA, MD, MI, NY, OH, OR, and PA.

## Key facts

- **Recall number:** Z-2497-2021
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-17
- **Report date:** 2021-09-29
- **Termination date:** 2024-01-12

- **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-2497-2021

## Citation

> AI Analytics. FDA recall Z-2497-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2497-2021. Source: US FDA. Licensed CC0.

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