Olympus SOLTIVE Pro Laser System Recall: Inconsistent Treatment Parameters
Olympus recalls SOLTIVE Pro SuperPulsed Laser Systems with inconsistent treatment parameters. Recalled units may not follow instructions, risking improper procedures. Contact Olympus for details.
Lower-risk recall
Preset treatment parameters are not consistently being used in accordance with the IFU.
Contact the company
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. Read more at govinfonow.com/recall/52491-olympus-soltive-pro-laser-system-recall-inconsistent-treatment-parameters.
Source Summary by GovInfoNow · govinfonow.com/recall/52491-olympus-soltive-pro-laser-system-recall-inconsistent-treatment-parameters · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1715-2025
Cite this page
“Olympus SOLTIVE Pro Laser System Recall: Inconsistent Treatment Parameters.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52491-olympus-soltive-pro-laser-system-recall-inconsistent-treatment-parameters. Based on FDA recall #Z-1715-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1715-2025%22&limit=1).
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
What to do — step by step
Check Product Model
Identify if your laser system has model numbers TFL-SLS or TFL-PLS.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of AU, CA, SG, DE, JP, HK.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 33 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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.