FDA recall, , Moderate risk
Lutronic CLARITY II Laser System
The Clarity II Laser System can spark or pop and potentially burn patients.
Summary by Recall Canary from the FDA notice
What happened
Lutronic Corporation is recalling the CLARITY II Laser System, Model No. 1110200210, because of reports of devices sparking/popping and potentially burning patients. The company began the recall on January 27, 2026, and the FDA added it to the Enforcement Report on March 12, 2026.
The recalled devices were distributed worldwide, including the US Nationwide and the countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand. The FDA classified the recall on March 12, 2026, and it was in the FDA's weekly enforcement report on March 18, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number matches.
Clarity II Laser System
- Model number
- 1110200210
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.
- Company
- Lutronic CorporationGoyang, Korea (the Republic of)
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98372
- Recall number
- Z-1558-2026
- Quantity recalled
- 1,525 units
All recalls from Lutronic Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
