# FDA recall Z-0717-2024

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2023-12-04.

## Product

Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC

## Reason for recall

The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination.

## Distribution

US Nationwide. Global Distribution

## Key facts

- **Recall number:** Z-0717-2024
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-04
- **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-0717-2024

## Citation

> AI Analytics. FDA recall Z-0717-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0717-2024. Source: US FDA. Licensed CC0.

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