Agency classClass IIOur severity:Severe FDA (Devices)·Z-1921-2025·Announced 2025-06-18

SOLTIVE Premium SuperPulsed Laser System surgical instrument thermal incident

Olympus is recalling the SOLTIVE Premium SuperPulsed Laser System due to risk of thermal incidents including smoke, sparks, burning, or flames during clinical use caused by fiber fracturing.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall involving a surgical instrument with risk of thermal incidents (smoke, sparks, burning, flames) during clinical use. The hazard directly creates risk of injury to patients and operating room staff, meeting the Class II with risk-of-harm criterion for Severe classification.

Plain-English summary

Olympus Corporation of the Americas is recalling the SOLTIVE Premium SuperPulsed Laser System (models TFL-PLS and TFL-PLS-JA). The devices are powered laser surgical instruments used in ureteroscopy, percutaneous nephrolithotomy (PCNL), and potential soft tissue applications.

The recall is due to a potential for thermal incidents, including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. Fiber fracturing is identified as the cause of, or a contributing factor to, these thermal incidents.

Approximately 1,549 units have been distributed worldwide, including 1,025 units in the United States and 524 units internationally (Australia, Canada, Chile, Germany, Hong Kong, Japan, and Singapore). Healthcare providers and facilities using these devices should contact Olympus Corporation of the Americas for instructions on device management and replacement options.

The recalled product

Product: Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only); Software Version: N/A Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and…
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Surgical Laser System
Hazard: thermal-incident
fire-hazard
fiber-fracture

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-PLS-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 →

Same manufacturer · Olympus Corporation of the Americas

See all →

Moderate
Olympus DisplayPort Cable Recalled for Video Dropout Risk
FDA (Devices) · 2026-10-07
Moderate
Olympus M3 Gold Autoclavable Foroblique Telescope Recalled for Sterilization Labeling Discrepancy
FDA (Devices) · 2026-10-07
Moderate
Olympus M3 Gold Autoclavable Lateral Telescope 70 Recalled for Sterilization Labeling Discrepancies
FDA (Devices) · 2026-10-07
Moderate
Olympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label
FDA (Devices) · 2026-09-30
Severe
Olympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30

Same hazard · thermal incident