Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only); Software Version: N/A Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: N/A
Class I - DangerousWhat Should You Do?
- Check if you have this product: All lot/serial numbers for the following products: TFL-PLS UDI: 00821925044111; TFL-PLS-JA (Japan only);
- 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.
Recall Details
- Company:
- Olympus Corporation of the Americas
- Reason for Recall:
- Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only); Software Version: N/A Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: N/A
Product Codes/Lot Numbers:
All lot/serial numbers for the following products: TFL-PLS UDI: 00821925044111; TFL-PLS-JA (Japan only);
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1921-2025
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