Olympus Soltive Reusable Laser Fibers Risk of Thermal Incidents
Olympus Soltive laser fibers used in surgical procedures may fracture, creating a risk of thermal incidents including smoke, sparks, and burning during use.
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 is an FDA Class II recall involving a risk-of-harm product where thermal incidents with potential for burns and fire exposure during surgical use have been identified. No injuries or illnesses have been reported, which places it at the High severity level per the rubric.
Plain-English summary
Olympus Corporation of the Americas is recalling Soltive Reusable Laser Fibers, which are surgical devices that deliver laser energy from a laser console to the treatment site. The recalled models include TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, and Japan-specific variants.
The devices have a potential for thermal incidents during clinical use, including unexpected occurrence of smoke, sparks, burning, or unsteady flames. These thermal incidents are caused by or contributed to by fracturing of the fiber.
Approximately 2,675 units have been distributed worldwide, with 190 units distributed in the United States and 2,485 units distributed internationally in Australia, Canada, Chile, Germany, Hong Kong, Japan, and Singapore. All lot numbers of the affected models are included in this recall.
Healthcare facilities and practitioners using these devices should discontinue use and contact Olympus Corporation of the Americas for instructions regarding device removal or replacement.
The recalled product
- Product
- Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL-FBX940R-JA (Japan Only), TFL-FBX365R-JA (Japan Only), TFL-FBX200BS-JA (Japan Only), TFL-FBX150R-J
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- thermal-incident
- fire
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 (5)
- TFL-FBX365R-JA (Japan Only)
- TFL-FBX200BS-JA (Japan Only)
- TFL-FBX150R-JA (Japan Only)
- TFL-FBX200R-JA (Japan Only)
- TFL-FBX550R-JA (Japan Only)
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03