FDA Medical devices recall ·
Diowave Laser System recall
- Recall number
- Z-2162-2026
- Date
- (initiated January 9, 2026)
- Company / brand
- Technological Medical Advancements LLC
1601 Belvedere Rd Ste E-180, West Palm Beach, FL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 16
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Diowave Laser System, REF: Diowave 250W
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81
Distribution
US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
States: California District of Columbia Florida Maryland Michigan Minnesota Pennsylvania Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2162-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.