The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1715-2025·Announced 2025-05-07

Olympus SOLTIVE Pro SuperPulsed Laser System procedural parameter issue

Olympus is recalling the SOLTIVE Pro SuperPulsed Laser System because preset treatment parameters may not be consistently applied according to the instructions for 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall. The hazard is a procedural or operational issue with preset parameters not being consistently applied per instructions; no illnesses, injuries, or deaths have been reported. The issue is technical in nature and addresses potential operational risk rather than an immediate safety threat.

Plain-English summary

Olympus Corporation of the Americas is recalling the SOLTIVE Pro SuperPulsed Laser System (model numbers TFL-SLS and TFL-PLS), a powered laser surgical instrument used in ureteroscopy, percutaneous nephrolithotomy (PCNL), and soft tissue applications. The recall affects 189 units distributed nationwide in the United States and internationally to Australia, Canada, Singapore, Germany, Japan, and Hong Kong.

The reason for the recall is that preset treatment parameters are not being consistently used in accordance with the instructions for use. This discrepancy could affect the proper functioning and safety of the device during surgical procedures.

Olympus is notifying customers of the recall and recommending appropriate corrective actions. Customers should contact their Olympus representative or refer to official recall information for specific guidance on the affected devices and next steps.

For additional information about this recall, visit the FDA website at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-1715-2025 or contact Olympus Corporation of the Americas.

The recalled product

Product
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and…
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Surgical Laser System
Hazard
Affected units
189

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 (3)

  • SOLTIVE Pro SuperPulsed Laser System: UDI-DI: TFL-SLS - 00821925044135
  • TFL Standard Laser Unit UDI-DI: TFL-CPLU - 00821925044586
  • TFL-CSLU - 00821925044593

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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