Moderate riskFDA DeviceApr 8, 2026Class II

Olympus SOLTIVE Pro SuperPulsed Laser System recalled for power supply defect

Olympus identified a defect in the 24V power supply module in some SOLTIVE Pro laser systems that may cause the device to stop working. In some cases, smoke or a burning smell may occur inside the laser console, though the design contains any smoke within the enclosure where it will self-extinguish.

From the FDA notice · Read the official notice ↗ · All Olympus recalls

What to do

Check if your SOLTIVE Pro laser system serial number matches the affected list provided by Olympus
Stop using the device immediately if your unit is on the recall list
Contact Olympus for instructions on repair or replacement of the power supply module

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU 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
Sold in: Nationwide
Made for: All ages (0 months and older)

This recall covers 2 products — see all of them.

Details

Units affected: 32 units
Illnesses reported: None reported
Manufactured in: 3500 Corporate Pkwy, Center Valley, PA, United States
Classification: Class II
Recall number: Z-1695-2026

In the FDA's words

Description: Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU 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 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. Laser System: TFL-SLS; UDI: 00821925044135; Component Part: TFL-CSLU; UDI: 00821925044593; Serial #: MDUF190114, MDUF220073, MDUF220331, MDUF220353, MDUF220354, MDUF220356, MDUF220411, MDUF220412, MDUF220413, MDUF220414, MDUF220427, MDUF220451, MDUF220453, MDUF220454, MDUF220455, MDUF220456, MDUF230004, MDUF230005, MDUF230006, MDUF230007, MDUF230076, MDUF230140, MDUF230141, MDUF230163, MDUF230164, MDUF230166, MDUF230167, MDUF230234, MDUF230283, MDUF230284, MDUF230331, MDUF230332, MDUF230361, MDUF230362, MDUF230363, MDUF230364, MDUF230365, MDUF230366, MDUF230411, MDUF230412, MDUF230413; Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Chile, Europe, Singapore, Australia, and Hong Kong. Affected quantity: 32 units
Hazard: 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.

2 products in this recall

Olympus SOLTIVE laser systems recalled for power supply risk

Olympus is recalling some SOLTIVE laser systems because a 24V power supply module may fail and make the system inoperable. The defect may also cause smoke or a burning smell, which is designed to stay inside the laser console and extinguish itself. No injuries have been reported. The recall covers 2 products, with 440 units affected, distributed in the US and several other countries.

The agency lists each product separately. Check every one you might have.

Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TF…
Z-1694-2026 · 408 units
Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU… (this page)
Z-1695-2026 · 32 units