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Lower risk Medical device recall · FDA · Published January 29, 2024

Olympus SOLTIVE Pro SuperPuls: Non-compliant power cord recall

Olympus recalls SOLTIVE Pro SuperPulsed Laser devices with non-compliant power cords that may not fit standard plugs in some regions. Affected units include all TFL-SLS models sold globally.

🇺🇸 FDA recall #Z-1384-2024Medical deviceOlympus ›
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Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229
✎ GovInfoNow plain-language explainer

What happened, in plain English

Olympus is recalling all SOLTIVE Pro SuperPulsed Laser devices (TFL-SLS) due to a potential power cord issue that could prevent proper plug connection in regions using different electrical standards. This could lead to improper use or damage if the device isn't connected correctly. Read more at govinfonow.com/recall/56231-olympus-soltive-pro-superpuls-non-compliant-power-cord-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/56231-olympus-soltive-pro-superpuls-non-compliant-power-cord-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1384-2024

Cite this page

“Olympus SOLTIVE Pro SuperPuls: Non-compliant power cord recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56231-olympus-soltive-pro-superpuls-non-compliant-power-cord-recall. Based on FDA recall #Z-1384-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1384-2024%22&limit=1).

Why it’s dangerous

The power cord may not match the electrical plug types used in certain regions, causing the device to not connect properly. This could lead to improper use or potential damage if the device isn't connected correctly.

Who’s affected

Users of the SOLTIVE Pro SuperPulsed Laser in regions with non-Type B or Type E/F plug systems are most at risk. This includes consumers who purchased the device globally.

How to tell if you have this one

Check for the model number TFL-SLS on the device. All units, including those with serial numbers, are affected. The recall covers all regions where the device was sold.

  • Brand
    Olympus
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Domestic: OUS Only; International distribution in the states of Australia, Chile, Germany, Hong Kong, Japan, New Zealand and Singapore.
Recall numberProduct, codes & lotsQuantity
Z-1384-2024SOLTIVE Pro SuperPulsed Laser (TFL-SLS ); Model Number: TFL-SLS; UDI/DI: 00821925044135; All serial numbers.17 Units (OUS Only)
Z-1385-2024SOLTIVE Premium SuperPulsed Laser (TFL-PLS ); Model Number: TFL-PLS; UDI/DI: 00821925044111; All serial numbers.203 Units (OUS Only)
Based on the official FDA remedy

What to do — step by step

  1. Check Power Cord Compatibility

    Ensure the power cord matches the electrical plug type in your region. If it does not, stop using the device until a compatible cord is found.

How this recall unfolded

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Jan 29, 202412. FDA classified it Class II: Mar 27, 202423. Published in FDA’s Enforcement Report: Apr 3, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. 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-1384-2024 (January 29, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1384-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA