Olympus recalls Soltive SuperPulsed Laser Fibers (models TFL-FBX150BS to TFL-FBX940S) due to potential smoke, sparks, or fire during surgical procedures. Affected units may fracture and cause thermal incidents.
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.
Olympus is recalling Soltive SuperPulsed Laser Fibers that could cause smoke, sparks, or fire during surgery due to fiber fracturing. This poses a risk of burns or fire to patients and staff if the fibers are used without proper safety measures.
The fibers can fracture during clinical use, leading to unexpected smoke, sparks, burning, or unsteady flames. This thermal incident could cause burns or fire to patients and medical staff if the fibers are not properly secured.
Surgical teams using the recalled Soltive SuperPulsed Laser Fibers for procedures. Patients and staff at medical facilities using these fibers are at risk of burns or fire if the fibers fracture during surgery.
Check for model numbers TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, or the Japan-only variants. These fibers are used in surgical procedures to deliver laser energy from the console to the treatment site.
Discontinue use of the recalled Soltive SuperPulsed Laser Fibers if they are in clinical use.
Reach out to Olympus Corporation of the Americas for guidance on safe disposal or replacement options.
The affected models are TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, and Japan-only variants (TFL-FBX150BS-JA, TFL-FBX550S-JA, TFL-FBX940S-JA, TFL-FBX200BS-JA, TFL-FBX150S-JA, TFL-FBX200S-JA, TFL-FBX365S-JA).
The fibers can fracture during clinical use, causing potential smoke, sparks, burning, or unsteady flames, which may lead to thermal incidents.
Check the model number on the product. The affected models are listed in the recall notice, including the Japan-only variants.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1922-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1922-2025 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
