Theralase Inc.: Medical Device Recall in 2019 - (Recall #: Z-0607-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.

Product Classification:

Class III

Date Initiated: September 26, 2019

Date Posted: December 11, 2019

Recall Number: Z-0607-2020

Event ID: 84168

Reason for Recall:

Device was shipped without a Unique Device Identification (UDI) label and a separate label identifies the power pack as CE Marked when the device has not yet received the CE Mark.

Status: Terminated

Product Quantity: 306 units

Code Information:

Serial Numbers on TLC-2002 Power Pack with CE Mark without CE approval: 3012 to 3204, inclusive; and 3202 to 3350 inclusive. Serial Number 3204 was sold abroad

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, LA, MD, MN, NC, NJ, NM, NY, OR, WI and countries of AU, BH, CA, HK, JO, MX, PK, PH.

Voluntary or Mandated:

Voluntary: Firm initiated