Quick Facts at a Glance
- Recall Date
- February 27, 2026
- Hazard Level
- HIGH
- Brand
- Olympus Corporation of the Americas
- 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 Corporation of the Americas
- Product type
- Medical Laser System
- Model numbers
- TFL-PLS, TFL-CPLU
- 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 Premium Laser System is a high-power surgical laser platform used for soft tissue ablation with hemostasis. It is designed for precise tissue vaporization while limiting char and necrosis. The recall involves a power-supply defect that could interrupt operation during use.
Why This Is Dangerous
A defect in the 24V power supply module may cause the device to stop functioning. Smoke or a burning smell may occur, but the issue is contained within the console enclosure and self-extinguishing.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The recall could disrupt procedures and require immediate device shutdowns. There are no reported injuries yet. Hospitals may need to substitute equipment and await a replacement or service action.
Practical Guidance
How to identify if yours is affected
- Verify device is SOLTIVE Premium Laser System model TFL-PLS.
- If a match, stop using the device and contact Olympus for instructions.
Where to find product info
Serial numbers and UDI are printed on the device label. UDI for laser system is 00821925044111. Component UDI is 00821925044586.
What timeline to expect
Recall actions and service or replacement will be coordinated by Olympus. Affected units should remain non-operational until cleared by the company.
If the manufacturer is unresponsive
- Document all communications with Olympus and your institution.
- Escalate to regulatory authorities if needed.
- Seek alternative equipment to maintain patient care while awaiting action.
How to prevent similar issues
- Verify future replacement parts and service bulletins for power supply modules.
- Confirm any recalls during pre-procedure equipment checks.
- Maintain an updated log of device serials and recalls for equipment management.
Documentation advice
Keep the recall notice, serial numbers, device label, and all correspondence with Olympus. Save incident reports and service logs for records.
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Product Details
Product: Olympus SOLTIVE Premium Laser System, Model TFL-PLS, Component TFL-CPLU UDI (Laser system): 00821925044111 UDI (Component): 00821925044586 Serial numbers included: MDUF220005, MDUF220437, MDUF220446, MDUF190072, MDUF200324, MDUF210030, MDUF210204, MDUF210379, MDUF220001, MDUF220002, MDUF220003, MDUF220007, MDUF220008 Quantity: 408 units Distribution: Worldwide, including US nationwide, Canada, Chile, Europe, Singapore, Australia, and Hong Kong Sold at: Unknown/Worldwide distribution
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model: TFL-PLS; Component: TFL-CPLU
- UDI laser system: 00821925044111; UDI component: 00821925044586
- Serials include MDUF220005, MDUF220437, MDUF220446, MDUF190072, MDUF200324, MDUF210030, MDUF210204,
- Hazard: 24V power supply defect may cause inoperability and smoke/burning smell
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Safety Guide
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