Theralase Inc.: Medical Device Recall in 2020 - (Recall #: Z-1354-2020)

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 Classification:

Class III

Date Initiated: September 26, 2019

Date Posted: March 4, 2020

Recall Number: Z-1354-2020

Event ID: 84843

Reason for Recall:

905 nm laser diodes may be below rated power output.

Status: Terminated

Product Quantity: 92 units

Code Information:

Serial Numbers: 3245 to 3336 inclusive

Distribution Pattern:

USA; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania

Voluntary or Mandated:

Voluntary: Firm initiated