Olympus recalls SOLTIVE Pro SuperPulsed Laser Systems (TFL-SLS, TFL-SLS-JA) due to potential thermal incidents like smoke, sparks, or burning during surgery. Affected units may have fiber fracturing causing safety risks.
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 Pro SuperPulsed Laser Systems that could cause thermal incidents such as smoke, sparks, or burning during surgery due to fiber fracturing. This poses a risk of injury to patients or staff if the device malfunctions.
The laser system's fiber can fracture during use, leading to unexpected thermal events like smoke, sparks, or unsteady flames. This could cause burns or other injuries to people in the operating room.
Surgical teams and hospitals using the SOLTIVE Pro SuperPulsed Laser Systems (model TFL-SLS or TFL-SLS-JA for Japan) are affected. Patients and medical staff are at risk if the device fractures during procedures.
Check for model numbers TFL-SLS or TFL-SLS-JA (Japan only) on the device. The product was sold with unique identifiers (UDI) like 00821925044135.
Identify the model number on the device to confirm if it is TFL-SLS or TFL-SLS-JA (Japan only).
Reach out to Olympus Corporation of the Americas for further assistance with the recall.
The affected models are TFL-SLS and TFL-SLS-JA (Japan only).
The recall is due to potential thermal incidents like smoke, sparks, or burning caused by fiber fracturing during clinical use.
The recall record does not specify a fix or remedy; affected units should be checked and contacted for assistance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1920-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1920-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
