RegWardenFDA facility compliance records
Recall

Class II — Technological Medical Advancements LLC

Recalling firmTechnological Medical Advancements, LLC
Registered facilityTECHNOLOGICAL MEDICAL ADVANCEMENTS, LLC (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonSoftware 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.
ProductDiowave Laser System, REF: Diowave 250W
Quantity16
DistributionUS Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
Initiated2026-01-09
Classified2026-05-11
Recall numberZ-2162-2026
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Technological Medical Advancements LLC (Z-2162-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98507/

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