# FDA recall Z-1695-2026

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2026-02-27.

## Product

Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System  Product Name: SOLTIVE Pro Laser System TFL-SLS  Model/Catalog Number: TFL-SLS containing TFL-CSLU  Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis.  Component: No

## Reason for recall

Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.

## Distribution

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

## Key facts

- **Recall number:** Z-1695-2026
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-27
- **Report date:** 2026-04-08

- **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-1695-2026

## Citation

> AI Analytics. FDA recall Z-1695-2026. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-1695-2026. Source: US FDA. Licensed CC0.

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