FDA recall, , Moderate risk
Olympus SOLTIVE Premium and Pro Laser Systems
The Soltive Pro and Premium laser systems may become inoperable and emit smoke or a burning smell.
Summary by Recall Canary from the FDA notice
What happened
Olympus Corporation of the Americas, located in Center Valley, Pennsylvania, began a recall on February 27, 2026, for the Soltive Premium Laser System TFL-PLS and the Soltive Pro Laser System TFL-SLS. 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.
The products are electricity powered device assemblies which emit a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Distribution was worldwide, including US Nationwide and the countries of Canada, Chile, Europe, Singapore, Australia, and Hong Kong. The FDA added the recall to its Enforcement Report on March 30, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Olympus SOLTIVE Premium SuperPulsed Laser System SOLTIVE Premium Laser System TFL-PLS
- UDI-DI
- 00821925044111
- 00821925044586
- Model/Catalog number
- TFL-PLS containing TFL-CPLU
Olympus SOLTIVE Pro SuperPulsed Laser System SOLTIVE Pro Laser System TFL-SLS
- UDI-DI
- 00821925044135
- 00821925044593
- Model/Catalog number
- TFL-SLS containing TFL-CSLU
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Europe, Singapore, Australia, and Hong Kong.
- Company
- Olympus Corporation of the AmericasCenter Valley, Pennsylvania
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98422
- Recall numbers
- Z-1694-2026 to Z-1695-2026
All recalls from Olympus Corporation of the Americas
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
