The Recall Desk

FDA (Devices) recall action 98422

Olympus Corporation of the Americas recalled 2 products on 2026-04-08

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2026-04-08
Critical
0
Units
440

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2026-04-08

    Olympus SOLTIVE Premium laser power supply may fail producing smoke

    Olympus is recalling SOLTIVE Premium SuperPulsed Laser Systems because a potential defect in the 24V power supply module may render the system inoperable and produce smoke or a burning smell.

    Product
    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2026-04-08

    Olympus SOLTIVE Pro laser power supply may fail producing smoke

    Olympus is recalling SOLTIVE Pro SuperPulsed Laser Systems because a potential defect in the 24V power supply module may render the system inoperable and produce smoke or a burning smell.

    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 tis
    Category
    Distribution
    0 states