The Recall Desk
Agency classClass IIIOur severity:LowFDA (Devices)·Z-0606-2020·Announced 2019-12-11

Theralase TLC-2000 Laser System Recalled for Missing UDI Labels

Theralase Inc. is recalling 41 TLC-2000 Therapeutic Medical Laser Systems because they were shipped without required Unique Device Identification (UDI) labels.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/packaging defect (missing UDI label) rather than a functional safety hazard.

Plain-English summary

Theralase Inc. is recalling 41 units of the TLC-2000 Therapeutic Medical Laser System, a device used for the temporary relief of knee pain. The recall was initiated because the devices were shipped without a Unique Device Identification (UDI) label.

The affected units were distributed worldwide, including nationwide distribution in the United States across the states of AZ, CA, CO, FL, GA, IL, IN, LA, MD, MN, NC, NJ, NM, NY, OR, and WI, as well as in the countries of AU, BH, CA, HK, JO, MX, PK, and PH. Specific serial numbers for the recalled units are listed in the official recall documentation.

Consumers and healthcare providers with this device should contact Theralase Inc. for instructions on how to proceed. The recall is classified as Class III by the FDA, indicating that the violation is not likely to cause adverse health consequences.

The recalled product

Product
TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
Manufacturer
Theralase Inc.
Category
Medical Device — Therapeutic Laser
Hazard
Affected units
41

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Serial Numbers: 3015
  • 3022
  • 3037
  • 3040
  • 3047
  • 3052
  • 3055
  • 3074
  • 3076
  • 3080
  • 3100
  • 3101
  • 3102
  • 3103
  • 3123
  • 3127
  • 3129
  • 3131
  • 3132
  • 3137

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Theralase Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Theralase Inc.

See all →

Similar recalls