Reported Apr 8, 2026 · Ongoing
Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS…
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- Brand NameOlympus SOLTIVE Premium
- SuperPulsed Laser System Product NameSOLTIVE Premium Laser
- System TFL-PLS Model/Catalog NumberTFL-PLS
- containing TFL-CPLU Product DescriptionAn 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
- ComponentNo
- Lot codes and dates
- Laser systemTFL-PLS
- UDI00821925044111
- Component PartTFL-CPLU
- UDI
918 of 918 codes
00821925044586Serial #: MDUF220005MDUF220005MDUF220437MDUF220437MDUF220446MDUF220446MDUF190072MDUF200324MDUF210030MDUF210204MDUF210379MDUF220001MDUF220002MDUF220003MDUF220007MDUF220008MDUF220009MDUF220010MDUF220011MDUF220012MDUF220013MDUF220014MDUF220015MDUF220016MDUF220017MDUF220018MDUF220019MDUF220020MDUF220021MDUF220022MDUF220023MDUF220024MDUF220025MDUF220026MDUF220027MDUF220028MDUF220029MDUF220030MDUF220031MDUF220032MDUF220033MDUF220034MDUF220035MDUF220036MDUF220037MDUF220038MDUF220039MDUF220040MDUF220042MDUF220043MDUF220044MDUF220045MDUF220046MDUF220047MDUF220048MDUF220049MDUF220050MDUF220051MDUF220052
- Amount recalled
- 408 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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