The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1920-2025·Announced 2025-06-18

SOLTIVE Pro SuperPulsed Laser System surgical instrument thermal incident

Olympus Corporation of the Americas is recalling the SOLTIVE Pro SuperPulsed Laser System due to risk of unexpected smoke, sparks, burning, or unsteady flames caused by fiber fracturing during clinical use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving a risk-of-harm defect (thermal hazard with potential for burn/fire). The source text does not report any injuries or illnesses; the hazard is characterized as a potential risk during clinical use. Per the rubric, this pattern matches the High severity threshold for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling the SOLTIVE Pro SuperPulsed Laser System (models TFL-SLS and TFL-SLS-JA) worldwide. The systems are powered laser surgical instruments used in ureteroscopy, PCNL, and potential soft tissue applications.

The recall is due to a potential for thermal incidents during clinical use, including an unexpected occurrence of smoke, sparks, burning, or unsteady flames. These thermal incidents are caused by, or contributed to by, fracturing of the fiber component.

A total of 201 units have been distributed (100 in the United States and 101 outside the United States) across Australia, Canada, Chile, Germany, Hong Kong, Japan, and Singapore. Affected devices carry all lot and serial numbers for models TFL-SLS (UDI: 00821925044135) and TFL-SLS-JA (Japan only).

Users of the SOLTIVE Pro SuperPulsed Laser System should contact Olympus Corporation of the Americas for guidance on managing the risk of thermal incidents during use.

The recalled product

Product
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to…
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Surgical Laser System
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • TFL-SLS-JA (Japan Only)

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Olympus Corporation of the Americas

See all →

Same hazard · thermal incident

See all →

Similar recalls