# FDA recall Z-2504-2024

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2024-05-31.

## Product

Soltive Premium SuperPulsed Laser System, Model TFL-PLS

## Reason for recall

Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.

## Key facts

- **Recall number:** Z-2504-2024
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-31
- **Report date:** 2024-08-14

- **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-2504-2024

## Citation

> AI Analytics. FDA recall Z-2504-2024. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-2504-2024. Source: US FDA. Licensed CC0.

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