# FDA recall Z-0748-2024

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2023-12-01.

## Product

SOLTIVE SuperPulsed Laser Fibers  Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS

## Reason for recall

Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to break during use, which may cause burns, procedure delays, prolonged surgery, and foreign body in patient.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Europe, Hong Kong, Australia, Japan, Singapore, and Latin America.

## Key facts

- **Recall number:** Z-0748-2024
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-01
- **Report date:** 2024-01-24

- **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-0748-2024

## Citation

> AI Analytics. FDA recall Z-0748-2024. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0748-2024. Source: US FDA. Licensed CC0.

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