FDA recall Z-2162-2026

Technological Medical Advancements LLC · Class II · device

Product

Diowave Laser System, REF: Diowave 250W

Reason for recall

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.

Distribution

US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.

Key facts

Status
Ongoing
Initiation date
2026-01-09
Report date
2026-05-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
West Palm Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2162-2026