Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for Recalled by Theralase Inc. Due to Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC,...

Date: September 26, 2019
Company: Theralase Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Theralase Inc. directly.

Affected Products

TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.

Quantity: 76 units

Why Was This Recalled?

Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC, 3.75 A, 90 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 4th edition specification) shipped versus Power supply (Model Number: TLC-2003) MENB1100A2403F01 (24 VDC, 4.2 A, 101 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 3rd edition specification)

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Theralase Inc.

Theralase Inc. has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report