Quick Facts at a Glance
- Recall Date
- January 27, 2026
- Hazard Level
- HIGH
- Brand
- Lutronic
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, CHILDREN
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
- Lutronic
- Product type
- Laser System
- Model numbers
- Model No. 1110200210, UDI: 08809447653723
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 27, 2026
Reported by FDA DEVICE
March 18, 2026
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Reports of devices sparking/popping and potentially burning patients.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Lutronic Corporation or your healthcare provider for instructions. Notification method: E-Mail
About This Product
The CLARITY II Laser System is a medical laser device used in clinical settings for cosmetic or surgical laser procedures.
Why This Is Dangerous
Electrical sparking or popping during operation can indicate a fault and may cause burns to patients.
Industry Context
This recall is not described as part of a broader industry pattern in the notice provided.
Real-World Impact
Clinics must halt use immediately. The recall involves 1,525 units distributed worldwide, creating a global safety and remediation effort for healthcare facilities.
Practical Guidance
How to identify if yours is affected
- Verify model number 1110200210 on the device label.
- Review serial numbers list for matches to your device.
Where to find product info
Refer to the recall notice emailed to affected healthcare providers and the FDA recall page.
What timeline to expect
Refunds or replacements typically follow manufacturer remediation of affected units; exact timeline to be issued by Lutronic.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Escalate to hospital compliance or regulatory authorities if the company is slow to respond.
How to prevent similar issues
- Before purchasing medical laser devices, verify recall history and service availability.
- Ensure manufacturer provides clear recall remediation steps and replacement options.
- Maintain updated contact information with the manufacturer for recall notices.
Documentation advice
Keep copies of recall notices, device labels (Model No., UDI, serial numbers), and all communications with the manufacturer. Take photos of the device labels and serial numbers.
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Product Details
Product: CLARITY II Laser System. Model No.: 1110200210. UDI: 08809447653723. Serial numbers include: C3023K024, C3022B006, C3025D028, C3022L031, C3024D027, C3022H015, C3024K033, C3019J018, C3024K030, C3025B076, C3023K043, C3021K002, C3025E050, C3025E035, C3022L010, C3023G009, C3023J037, C3021D021. Quantity: 1,525 units. Distribution: Worldwide, including US nationwide and Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand. Sold since: Unknown. Price: Unknown.
Reported Incidents
Reports of sparking and popping during use. No injury counts are provided in the recall notice.
Key Facts
- Distributions include US nationwide and Canada, plus several Asian markets
- Hazard: sparking/popping and burn risk
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Safety Guide
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