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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Olympus
- Product type
- Medical Laser System
- Model numbers
- TFL-SLS, TFL-CSLU, MDUF190114, MDUF220073, MDUF220331, MDUF220353, MDUF220354, MDUF220356 +10 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 27, 2026
Reported by FDA DEVICE
April 8, 2026
RecallRadar source check
April 15, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Verify model: SOLTIVE Pro Laser System, model TFL-SLS.
- Verify component: TFL-CSLU.
- 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.
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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
- 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,
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Safety Guide
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