Olympus recalls SOLTIVE Premium SuperPulsed Laser Systems due to potential thermal incidents like smoke, sparks, or flames during surgery. Affected models include TFL-PLS and TFL-PLS-JA (Japan only).
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 its SOLTIVE Premium SuperPulsed Laser Systems because the laser fiber can fracture, causing thermal incidents such as smoke, sparks, or flames during surgery. This hazard could lead to serious injury if the device malfunctions during clinical use.
The laser fiber can fracture during clinical use, leading to thermal incidents like smoke, sparks, burning, or unsteady flames. These incidents could cause serious injury to patients or staff if they occur during surgery.
Surgical teams and hospitals using the SOLTIVE Premium SuperPulsed Laser Systems with model numbers TFL-PLS or TFL-PLS-JA (Japan only) are affected. Medical professionals performing procedures involving ureteroscopy, PCNL, or soft tissue applications are most at risk.
Check for model numbers TFL-PLS or TFL-PLS-JA (Japan only) on the device. The product was sold with specific UDI numbers: 00821925044111 for TFL-PLS.
Identify the model number on the device to confirm if it is TFL-PLS or TFL-PLS-JA (Japan only).
Reach out to Olympus Corporation of the Americas for further assistance or to confirm if your device is affected.
No, this recall specifically applies to the SOLTIVE Premium SuperPulsed Laser Systems with model numbers TFL-PLS or TFL-PLS-JA (Japan only).
Check the model number on your device and contact Olympus Corporation of the Americas for further instructions.
The recall does not specify a fix or repair; the remedy is null, so the device should not be used until further instructions are received from Olympus.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1921-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1921-2025 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.
