Theralase Inc.: Medical Device Recall in 2020 - (Recall #: Z-1326-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: September 26, 2019

Date Posted: February 26, 2020

Recall Number: Z-1326-2020

Event ID: 84845

Reason for Recall:

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)

Status: Terminated

Product Quantity: 76 units

Code Information:

Serial Numbers: 3275 to 3350 (inclusive)

Distribution Pattern:

Worldwide distribution - US Nationwide and countries Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania.

Voluntary or Mandated:

Voluntary: Firm initiated