FDAClass IIIDecember 11, 2019

TLC-2000 Therapeutic Medical Laser System recall

TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.

Why was TLC-2000 Therapeutic Medical Laser System recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
Recalling firm
Theralase Inc.
Quantity
41 units
Distribution
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.
Recall date
December 11, 2019
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls