Diowave Laser System, REF: Diowave 250W

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Technological Medical Advancements LLC
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Diowave Laser System, REF: Diowave 250W

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2162-2026