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Olympus Corporation of the Americas recalls Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalo
Recalled June 18, 2025 · FDA recall Z-1922-2025 · Olympus Corporation of the Americas
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. · FDA Class II
Units
551,154 units (417859 US, 133710 OUS)
Sold at
Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
Description
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.
Product
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.
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →