Recall Z-1694-2026 · GEX Powered Laser Surgical Instrument
Olympus Corporation of the Americas
Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No
| Date | Mar 30, 2026 (initiated Feb 27, 2026) |
| Status | Open, Classified |
| Reason | Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing. |
| Root cause | Process control |
| Action | On February 27, 2026 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Examine your inventory and identify any of the affected devices listed in the attachment. 2. Olympus requests that you acknowledge receipt of this letter through our recall web portal. 3. Olympus representatives will begin contacting customers to coordinate the service of affected unit(s). In the meantime, you may continue using your SOLTIVE Laser until the service is completed. Olympus will replace the 24V power supply module at no charge to you. Note: Any issues beyond the repla |
| Quantity | 408 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Chile, Europe, Singapore, Australia, and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242191 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Acc Olympus Surgical Technologies America, Aug 23, 2024 |