Olympus SOLTIVE Pro Laser System Recall: Inconsistent Treatment Parameters

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Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Olympus is recalling SOLTIVE Pro SuperPulsed Laser Systems because preset treatment parameters aren't consistently used as per the manufacturer's instructions. This could lead to improper procedures during surgery.

Why it’s dangerous

The laser system's preset treatment parameters aren't consistently applied according to the manufacturer's instructions. This inconsistency could lead to improper procedures during surgery, potentially causing complications.

Who’s affected

Surgical teams using the SOLTIVE Pro SuperPulsed Laser System for procedures like ureteroscopy or PCNL are affected. Medical professionals who use these systems are most at risk.

How to tell if you have this one

Check for model numbers TFL-SLS or TFL-PLS on the laser system. The product was sold with UDI-DI codes TFL-SLS - 00821925044135 and TFL-PLS - 00821925044111.

Brand
Olympus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Model
Identify if your laser system has model numbers TFL-SLS or TFL-PLS.

✎ GovInfoNow

Questions people ask

What is the hazard with this laser system?

The preset treatment parameters are not consistently used in accordance with the manufacturer's instructions.

How can I tell if my laser system is recalled?

Check for model numbers TFL-SLS or TFL-PLS on the laser system.

What should I do if I have a recalled system?

The recall does not specify a remedy, so contact Olympus directly for guidance.

Take action

Contact Olympus

We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1715-2025 — Olympus Olympus

Hello,

I own a Olympus that is covered by recall Z-1715-2025 from Olympus.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1715-2025 (April 4, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1715-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Olympus Corporation of the Americas recalls Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers:

Lower-risk recall