# FDA recall Z-0644-2024

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2023-11-20.

## Product

OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter)  Model:  LTF-S190-5     Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs.

## Reason for recall

Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in  the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-0644-2024
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-20
- **Report date:** 2024-01-17

- **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-0644-2024

## Citation

> AI Analytics. FDA recall Z-0644-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0644-2024. Source: US FDA. Licensed CC0.

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