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CLASS II · ModerateFDA

Technological Medical Advancements LLC recalls Diowave Laser System

📅 Jan 9, 2026 · 📍 Nationwide
Recalling company
Technological Medical Advancements LLC
Product
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Jan 9, 2026
Reported
May 20, 2026
Distribution
US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
Status
Ongoing
Quantity
16
Lot / codes
UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81
Company location
West Palm Beach, FL
Recall type
Voluntary: Firm initiated
Recall number
Z-2162-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2162-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.