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Diowave 250W Laser System
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MEDICAL DEVICE RECALLMODERATE

Diowave 250W Laser System

Diowave 250W Laser System recalled; software update needed to correct power output exceeding FDA-cleared 60W limit.

What to do

Contact Technological Medical Advancements LLC immediately to obtain and install the required software update. Do not operate the device until the update has been applied.

Recalled
Listed
Updated
Recall No.
Z-2162-2026
Agency
FDA
Firm
Technological Medical Advancements LLC
Recall ID
98507
Status
ONGOING

Why it was recalled

The Diowave 250W Laser System (REF: Diowave 250W) is being recalled because a software update is needed to correct the maximum average power output, which is currently operating at 70W beyond the FDA-cleared limit of 60W. The device is intended 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.

Is mine affected?

This recall covers the product below. If you have it, yours is affected.

Diowave Laser System, REF: Diowave 250W

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated
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Editorial summary by Recall Canary · summary updated 2026-05-12 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification