Olympus Corporation of the Americas Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: No Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: No
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
All lot/serial numbers for the following products: TFL-SLS UDI: 00821925044135, TFL-SLS-JA (Japan Only)
Products Sold
All lot/serial numbers for the following products: TFL-SLS UDI: 00821925044135; TFL-SLS-JA (Japan Only)
Olympus Corporation of the Americas is recalling Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Mod due to Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On May 6, 2025 URGENT: MEDICAL DECIVE CORRECTION letters were sent to customers. Actions Required: Our records indicate that your facility has purchased one or more of the affected products. Therefore, Olympus requires you to take the following actions: 1. Carefully read the content of this letter, including Appendix 1 detailing the relevant Instructions for Use sections. 2. Ensure all surgeons and personnel are completely knowledgeable and thoroughly trained on the content of this letter, the instructions provided for detecting fiber damage, Appendix 1, and the SOLTIVE Laser System and Fibers Instructions for Use. Include a copy of this letter with the Instructions for Use. You may continue to use the device as per this letter and the Instructions for Use. 3. Olympus requests that you acknowledge receipt of this letter through our recall web portal: a. Go to https://olympusamerica.com/recall b. Enter the recall number: "0470 c. Complete the form as instructed. 4. If you have further distributed this product, identify and forward them this letter. Olympus requests you to report any complaints, including fiber damage/breaks, smoke, sparks, flare, burning of a device or equipment, unsteady flames, steady flames and burns to a clinician or supporting staff occurring while using the SOLTIVE Laser Systems and SOLTIVE Laser Fibers. Olympus requests that you send the involved fiber(s) to Olympus for complaint investigation purposes. Please report complaints to our Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail Cynthia.Ow@Olympus.com.
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View official FDA recall noticePage updated: Jan 10, 2026
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