Diowave Laser System recall: Software Issue
Diowave Laser System, REF: Diowave 250W
Why was Diowave Laser System recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: G180DIOWAVESTEALTHMAX0. All software versions prior to, but not including V1.81
- Product
- Diowave Laser System, REF: Diowave 250W
- Recalling firm
- Technological Medical Advancements LLC
- Quantity
- 16
- Distribution
- US Nationwide distribution in the states of TX, CA, MI, MD, PA, FL, MN, DC, MI.
- Recall date
- May 20, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)