[pending] Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Ca
Pending LLM rewrite. Source: FDA_DEVICE Z-1923-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
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.
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
- Category
- Medical Device — Devices
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.
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