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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Olympus Corporation of the Americas: SOLTIVE SuperPulsed Lasers Recalled for Non-Compliant Power Cords

Agency Publication Date: March 27, 2024
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Summary

Olympus is recalling approximately 220 SOLTIVE Pro and SOLTIVE Premium SuperPulsed Laser systems because they may have been supplied with non-compliant power cords. These devices are used in medical laser procedures and were distributed primarily in international regions. The recall affects 17 units of the SOLTIVE Pro (TFL-SLS) model and 203 units of the SOLTIVE Premium (TFL-PLS) model. Consumers should identify their units by model and serial number and contact the manufacturer for guidance.

Risk

A non-compliant power cord can lead to electrical issues or equipment failure if used in regions where the plug configuration does not match local electrical standards (specifically regions not using Type B or Type E/F plugs).

What You Should Do

  1. Check your medical laser system to determine if it is a SOLTIVE Pro SuperPulsed Laser (Model TFL-SLS) or a SOLTIVE Premium SuperPulsed Laser (Model TFL-PLS).
  2. Locate the UDI/DI on your device: for SOLTIVE Pro, look for 00821925044135; for SOLTIVE Premium, look for 00821925044111. All serial numbers for these models are included in this recall.
  3. Verify if your facility is located in a region that uses power configurations other than Type B or Type E/F plugs, as these are the specific areas where non-compliant cords may have been supplied.
  4. Contact Olympus Corporation of the Americas or your local healthcare provider to report your unit and receive instructions on obtaining a compliant power cord.
  5. For additional information or questions regarding this device recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification and Guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: SOLTIVE Pro SuperPulsed Laser (TFL-SLS)
Model / REF:
TFL-SLS
UPC Codes:
00821925044135
Lot Numbers:
All serial numbers
Product: SOLTIVE Premium SuperPulsed Laser (TFL-PLS)
Model / REF:
TFL-PLS
UPC Codes:
00821925044111
Lot Numbers:
All serial numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94125
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: Authorized medical distributors
Manufactured In: United States
Units Affected: 2 products (17 Units (OUS Only); 203 Units (OUS Only))
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.