CLASS II ONGOING Device recall · Reported 8 Apr 2026 · FDA Enforcement Report
Soltive Pro Laser System Tfl-sls recalled by Olympus Corporation of the
Olympus Corporation of the Americas is recalling Soltive Pro Laser System Tfl-sls, distributed nationwide in the US. The recall was initiated on 27 Feb 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1695-2026
- FDA event ID
- 98422
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Feb 2026
- FDA classified
- 30 Mar 2026
- Reported
- 8 Apr 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 27 Feb 2026 | Recall initiated by company | |
| 30 Mar 2026 | Classified by FDA | +31 days |
| 8 Apr 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Europe, Singapore, Australia, and Hong Kong.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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;
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Europe, Singapore, Australia, and Hong Kong.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 98422This product is part of a recall event; the main page for the event is Soltive Premium Laser System Tfl-pls recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Soltive Premium Laser System Tfl-pls recalled | Olympus Corporation of the Americas | Device Malfunction | Nationwide |
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