Olympus Corporation of the Americas has recalled approximately 555,579 SOLTIVE Laser Systems and associated laser fibers, including the Pro and Premium consoles and various single-use and reusable fibers. These surgical devices are being recalled because the laser fibers may fracture during use, which can lead to unexpected smoke, sparks, burning, or unsteady flames. While no injuries have been reported to date, thermal incidents involving flames and smoke have occurred during clinical procedures. If your facility uses these systems, you should contact the manufacturer to arrange for necessary corrections or returns.
Fractured laser fibers can cause a sudden release of thermal energy, leading to sparks, smoke, or open flames during a medical procedure. This poses a significant fire risk in the operating room and could cause burns to the patient or surgical staff.
201 units affected (100 US, 101 OUS).
1549 units affected (1025 US, 524 OUS).
551,154 units affected (417,859 US, 133,710 OUS).
2,675 units affected (190 US, 2,485 OUS).
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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