Theralase Inc.: Medical Device Recall in 2019 - (Recall #: Z-0606-2020)

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, 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-0606-2020

Event ID: 84168

Reason for Recall:

Device was shipped without a Unique Device Identification (UDI) label.

Status: Terminated

Product Quantity: 41 units

Code Information:

Serial Numbers: 3015, 3022, 3037, 3040, 3047, 3052, 3055, 3074, 3076, 3080, 3100, 3101, 3102, 3103, 3123, 3127, 3129, 3131, 3132, 3137, 3139, 3155, 3162, 3166, 3171, 3183, 3187, 3200, 3206, 3227, 3245, 3266, 3268, 3293, 3296, 3297, 3305, 3308, 3318, 3321, 3332

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