Soltive SuperPulsed Laser Fibers Recalled for Thermal Incident Risk
Olympus is recalling Soltive SuperPulsed Laser Fibers due to potential thermal incidents including smoke, sparks, burning, and flames during surgical use, caused by fiber fracturing. No injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a risk-of-harm product with potential for thermal injury (burning, smoke, flames) caused by fiber fracturing during clinical use. No injuries, illnesses, or hospitalizations have been reported in the source text. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Olympus Corporation of the Americas is recalling Soltive SuperPulsed Laser Fibers (Single Use), which are delivery devices that transmit laser energy from the laser console to surgical treatment sites. The recall affects multiple models including TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, and Japan-only variants. Approximately 551,154 units are affected worldwide, including 417,859 in the United States.
The recall is prompted by the potential for thermal incidents, including unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. These incidents are caused by fracturing of the laser fiber.
The affected devices have been distributed worldwide, including throughout the United States and internationally to Australia, Canada, Chile, Germany, Hong Kong, Japan, and Singapore.
Healthcare providers using these laser fibers should stop using affected units and contact Olympus for instructions regarding return or replacement. Patients who have undergone surgery with these devices should consult their healthcare provider if they have concerns.
The recalled product
- 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
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- burn-injury
- fire
- thermal-incident
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- 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)
Distribution
Distributed nationwide across the United States.
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