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.
What this means for you
Illness, injury, or structural failure has been reported. 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 f
- Manufacturer
- Olympus Corporation of the Americas
- 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.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22