Olympus Corporation of the Americas has recalled approximately 82,200 units of SOLTIVE SuperPulsed Laser Fibers because the Instructions for Use (IFU) contain inconsistent guidance regarding cleaning, cleaving, and stripping the fiber tips. Using the product according to the current instructions can cause the laser fiber to break during a surgical procedure, potentially leaving a foreign body inside a patient or causing burns. This recall includes seven different model versions sold across the United States and worldwide. Consumers should contact Olympus or their healthcare provider for updated safety instructions and guidance.
If the fiber breaks during use due to incorrect preparation or cleaning, it can lead to patient burns, surgical delays, and the unintended presence of a foreign object (fiber fragments) within the patient's body.
Inconsistency in Instructions for Use corrected via firm notification letter.
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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