Agency classClass IIOur severity:High FDA (Devices)·Z-1695-2026·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the system may become inoperable mid-use and produce smoke, and no injuries are stated in the source.

Plain-English summary

Olympus is recalling the SOLTIVE Pro SuperPulsed Laser System, model TFL-SLS containing TFL-CSLU, a device that emits a high-power laser beam to vaporise or ablate soft tissue. About 32 units were distributed nationwide in the United States and to Canada, Chile, Europe, Singapore, Australia and Hong Kong. The FDA has classified this recall as Class II.

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. Olympus states that by design the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.

Affected product is identified by model TFL-SLS.

Facilities can identify affected systems by the model number above, and may contact Olympus for further information.

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…
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Surgical laser
Hazard: power-supply-defect
device-inoperable
smoke
procedure-risk
Affected units: 32

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Olympus Corporation of the Americas

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Same hazard · power supply defect