Olympus recalls Soltive reusable laser fibers (models TFL-FBX150R to TFL-FBX940R) due to potential smoke, sparks, and burning during clinical use. Affected units may fracture, causing 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 reusable laser fibers that could cause smoke, sparks, or burning during surgery. The fibers may fracture, leading to thermal incidents that could harm patients or staff.
The fibers can fracture during use, causing unexpected smoke, sparks, burning, or unsteady flames. This thermal incident may occur during surgery, potentially harming patients or staff.
Surgical teams using the recalled Soltive laser fibers in clinical settings are most at risk. Patients and medical staff handling these fibers during procedures could be affected.
Check for model numbers TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, or TFL-FBX940R (with or without JA suffix for Japan). These fibers were sold with specific lot numbers listed in the recall notice.
Discontinue use of the recalled Soltive laser fibers if you have them.
Reach out to Olympus Corporation of the Americas for guidance on next steps.
The affected models are TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, and TFL-FBX940R (with or without JA suffix for Japan).
The fibers can fracture during use, causing potential smoke, sparks, burning, or unsteady flames, which may lead to thermal incidents.
Check the model number on the product. Affected models include TFL-FBX150R to TFL-FBX940R with specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1923-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1923-2025 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.
