Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Recalled by Olympus Corporation of the Americas Due to Thermal injury following dusting and fragmenting treatment of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Olympus Corporation of the Americas directly.
Affected Products
Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological surgery
Quantity: 408 units
Why Was This Recalled?
Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Olympus Corporation of the Americas
Olympus Corporation of the Americas has 378 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report