The Recall Desk
Agency classClass IIIOur severity:LowFDA (Devices)·Z-0607-2020·Announced 2019-12-11

Theralase Laser Power Pack Recalled for Missing UDI and False CE Mark

Theralase Inc. is recalling 306 TLC-2002 Power Packs for the TLC-2000 Therapeutic Medical Laser System because they were shipped without a Unique Device Identification (UDI) label and incorrectly labeled as CE Marked.

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 FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issues are documentation and labeling errors (missing UDI, false CE mark) rather than functional safety defects.

Plain-English summary

Theralase Inc. is recalling 306 units of the TLC-2002 Power Pack component for the TLC-2000 Therapeutic Medical Laser System. This device is used for the temporary relief of knee pain. The recall was initiated because the devices were shipped without a Unique Device Identification (UDI) label. Additionally, a separate label incorrectly identifies the power pack as CE Marked, even though the device has not yet received CE approval.

The affected units have serial numbers ranging from 3012 to 3204 inclusive, and 3202 to 3350 inclusive. Serial number 3204 was sold abroad. The products were distributed worldwide and across the United States in the states of AZ, CA, CO, FL, GA, IL, IN, LA, MD, MN, NC, NJ, NM, NY, OR, and WI. International distribution included Australia, Bahrain, Canada, Hong Kong, Jordan, Mexico, Pakistan, and the Philippines.

Consumers and healthcare providers should stop using the affected power packs and contact Theralase Inc. for further instructions. The FDA has classified this as a Class III recall, indicating that the use of or exposure to the device is not likely to cause adverse health consequences.

The recalled product

Product
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
Manufacturer
Theralase Inc.
Category
Medical Device — Therapeutic Laser
Hazard
Affected units
306

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 (2)

  • inclusive
  • and 3202 to 3350 inclusive. Serial Number 3204 was sold abroad

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 →

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