FDA recall, , Moderate risk
Technological Medical Advancements Diowave Laser System
The Diowave Laser System operates beyond its cleared power output.
Summary by Recall Canary from the FDA notice
What happened
Technological Medical Advancements LLC of West Palm Beach, Florida, began a recall of the Diowave Laser System, REF: Diowave 250W, on January 9, 2026. The FDA added the recall to its Enforcement Report and classified it on May 11, 2026, and it was in the FDA's weekly enforcement report on May 20, 2026.
The agency stated a software update is needed for the system, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporarily increase local blood circulation, operating at a maximum average power output of 70W, which is beyond the FDA cleared 60W.
Distribution was in California, Florida, Maryland, Michigan, Minnesota, Pennsylvania, Texas and District of Columbia.
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?
Compare these details with yours, then check the recall notice to see which units are recalled.
Diowave Laser System, REF: Diowave 250W
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Texas, California, Michigan, Maryland, Pennsylvania, Florida, Minnesota, District of Columbia, Michigan.
- Company
- Technological Medical Advancements LLCWest Palm Beach, Florida
- Hazard
- Software 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
- 98507
- Recall number
- Z-2162-2026
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
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
