# FDA recall Z-2294-2021

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2021-06-30.

## Product

Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological surgery

## Reason for recall

Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets

## Distribution

US Nationwide Distribution   Foreign:  Canada	  Australia	  Japan	  Hong Kong	  Europe	  Singapore

## Key facts

- **Recall number:** Z-2294-2021
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-30
- **Report date:** 2021-08-25
- **Termination date:** 2024-01-26

- **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-2294-2021

## Citation

> AI Analytics. FDA recall Z-2294-2021. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-2294-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*