FDAFDA · Food and drugs·Recall number Z-2162-2026
Diowave Laser System, REF: Diowave 250W
Published May 20, 2026 · Recall initiated: January 9, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Technological Medical Advancements LLC
- Distributor
- US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
- Lot
- UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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