← FDA ENFORCEMENT
Z-2162-2026Class II

Technological Medical Advancements LLC

Recalling firm
Technological Medical Advancements LLC
Product type
Device
Status
Ongoing
Report date
2026-05-20
Distribution
US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
Firm state
FL
Product quantity
16
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Data Integrity
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.

Product description

Diowave Laser System, REF: Diowave 250W

Code / lot info

UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81

Other recalls SPEQ maps to Data Integrity
2026-07-15Class IICMR SURGICAL LIMITED2026-07-15Class IIMedtronic MiniMed, Inc.2026-07-01Class IIIPG Medical Corporation2026-06-24Class IIMedtronic Navigation, Inc.-Boxborough
See all Data Integrity recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.