HIGH

Olympus SOLTIVE Pro Laser System Recall 2026 — 32 Units Worldwide

Olympus recalled 32 SOLTIVE Pro SuperPulsed Laser System units distributed worldwide after a defect in the 24V power supply may render the device inoperable. The defect can cause smoke or a burning smell, but the issue is contained within the laser console enclosure and self-extinguishing. Stop using the device and follow the manufacturer’s recall instructions.

Quick Facts at a Glance

Recall Date
February 27, 2026
Hazard Level
HIGH
Brand
Olympus
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions

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About This Product

The SOLTIVE Pro is a high-power laser system used in soft tissue ablation with hemostasis and minimal charring. It is a complex medical device deployed in specialized clinical settings.

Why This Is Dangerous

A defect in the 24V power supply can render the system inoperable and may produce smoke or a burning odor. The issue is contained within the internal console enclosure and self-extinguishing.

Industry Context

This recall is not described as part of a broader industry pattern in the provided data.

Real-World Impact

The recall affects 32 units distributed worldwide. Healthcare facilities must halt use of affected devices and follow recall instructions to avoid potential interruptions in procedures and device downtime.

Practical Guidance

How to identify if yours is affected

  1. Verify model: SOLTIVE Pro Laser System, model TFL-SLS.
  2. Verify component: TFL-CSLU.
  3. Check serial numbers and UDI codes listed in the recall information.

Where to find product info

Device labels and the FDA recall page provide serials, UDI codes, and model identifiers.

What timeline to expect

Typical recall resolution timelines range from 4-8 weeks for refunds or replacements, depending on厂家 coordination.

If the manufacturer is unresponsive

  • Escalate to hospital system risk management or hospital compliance offices.
  • Document all attempts to contact Olympus and your healthcare provider.
  • Consider filing a report with the appropriate medical device regulatory body if the manufacturer is unresponsive.

How to prevent similar issues

  • Verify device compatibility and power supply integrity before use.
  • Maintain updated recall references and manufacturer communications.
  • When purchasing medical laser systems, verify certifications and ensure proper installation and servicing.
  • Document serial numbers, UDI, and purchase details for future recalls.

Documentation advice

Keep the recall notice, serial numbers, UDI codes, purchase records, and all correspondence with Olympus and healthcare providers for potential claims.

Product Details

Model/Catalog Number: TFL-SLS containing TFL-CSLU. Laser System: SOLTIVE Pro. UDI: 00821925044135 (TFL-SLS) and UDI: 00821925044593 (TFL-CSLU). Serial numbers include MDUF190114 and multiple codes MDUF220073, MDUF220331, MDUF220353, MDUF220354, MDUF220356, MDUF220411, MDUF220412, MDUF220413, MDUF220414, MDUF220427, MDUF220451, MDUF220453, MDUF220454, MDUF220455, MDUF220456. Quantity recalled: 32 units. Distribution: Worldwide including US nationwide and markets in Canada, Chile, Europe, Singapore, Australia, and Hong Kong.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 32 units recalled
  • Worldwide distribution including US, Canada, Chile, Europe, Singapore, Australia, Hong Kong
  • Laser System: SOLTIVE Pro; Model: TFL-SLS; Component: TFL-CSLU
  • Serials include MDUF190114, MDUF220073, MDUF220331, MDUF220353, MDUF220354, MDUF220356, MDUF220411,
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
6/ 10
Affected Groups
GENERAL
Injury Types
ELECTRICALBURN

Product Classification

Product TypeMedical Laser System
Sold At
Multiple Retailers

Product Details

Brand
Olympus
Model Numbers
TFL-SLS
TFL-CSLU
MDUF190114
MDUF220073
MDUF220331
+13 more
Affected States
ALL
Report Date
April 8, 2026
Recall Status
ACTIVE

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