SOLTIVE Premium SuperPulsed Laser (TFL-PLS )

Class I - Dangerous

What Should You Do?

Check if you have this product:
Model Number: TFL-PLS; UDI/DI: 00821925044111; All serial numbers.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Company:: Olympus Corporation of the Americas
Reason for Recall:: A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

SOLTIVE Premium SuperPulsed Laser (TFL-PLS )

Model Number: TFL-PLS; UDI/DI: 00821925044111; All serial numbers.

Always verify recall information with the official FDA source:

FDA Recall Number: Z-1385-2024

Olympus Corporation of the Americas

Class I - Dangerous

Potential for detachment of a distal tip component of the device during use.

Mar 23, 2026 Other Medical Devices View Details →

Olympus Corporation of the Americas

Class I - Dangerous

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Mar 25, 2026 Other Medical Devices Nationwide View Details →

Olympus Corporation of the Americas

Class I - Dangerous

Potential for detachment of a distal tip component of the device during use.

Mar 23, 2026 Other Medical Devices View Details →