FDAFDA · Food and drugs·Recall number Z-1922-2025
Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TLF-FBX940S, TFL-FBX150BS-JA (Japan Only), TFL-FBX550S-JA (Japan Only), TFL-FBX940S-JA (Japan Only), TFL-FBX200BS-JA (Japan Only), TFL-FBX150S-JA (Japan Only), TFL-FBX200S-JA (Japan Only), TFL-FBX365S-JA (Japan Only); Product Description: SOLTIVE Laser Fibers are delivery devices that transmit laser energy from the laser console to the treatment site through the fiber tip. The laser connector secures the device to the laser.
Published June 18, 2025 · Recall initiated: May 6, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
- Lot
- Lot Code: All lot numbers for the following products: TFL-FBX150BS UDI: 00821925043923; TFL-FBX200BS UDI: 00821925043985; TFL-FBX150S UDI: 00821925043886; TFL-FBX200S UDI: 00821925043947; TFL-FBX365S UDI: 00821925044005; TFL-FBX550S UDI: 00821925044043; TFL-FBX940S UDI: 00821925044081; TFL-FBX150BS-JA (Japan Only); TFL-FBX550S-JA (Japan Only); TFL-FBX940S-JA (Japan Only); TFL-FBX200BS-JA (Japan Only); TFL-FBX150S-JA (Japan Only); TFL-FBX200S-JA (Japan Only); TFL-FBX365S-JA (Japan Only);
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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