Diowave Laser System recall (Technological Medical Advancements LLC)
Medical deviceClass IIOngoing
Summary: Technological Medical Advancements LLC is recalling Diowave Laser System, REF: Diowave 250W. Reason: Software update is needed for laser systems, 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.
What is being recalled
Diowave Laser System, REF: Diowave 250W
Why
Software update is needed for laser systems, 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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI. (states named: California, District of Columbia, Florida, Maryland, Michigan, Minnesota, Pennsylvania, Texas)
How to tell if yours is affected
UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2162-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | January 9, 2026 |
| Reported | May 20, 2026 |
| Company | Technological Medical Advancements LLC |
| Company location | West Palm Beach, FL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 16 |
More recalls from Technological Medical Advancements LLC · all medical device recalls · recalls from January 2026