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Lower risk Medical device recall · FDA · Published September 26, 2019

Theralase TLC-2000 Laser System Recall: Laser Power May Be Too Low

Theralase recalls TLC-2:000 Therapeutic Medical Laser Systems with serial numbers 3245-3336 due to potential low laser power output. Affected units may not function as intended.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1354-2020Medical deviceTheralase ›
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Contact the company

Recalling firmTheralase Inc.41 Hollinger Rd · East York, Canada
✎ GovInfoNow plain-language explainer

Theralase is recalling TLC-2000 Therapeutic Medical Laser Systems with serial numbers 3245 to 3336 because the 905 nm laser diodes might not be producing the rated power. This could mean the device doesn't work properly for medical treatments. Read more at govinfonow.com/recall/66957-theralase-tlc-2000-laser-system-recall-laser-power-may-be.

Source Summary by GovInfoNow · govinfonow.com/recall/66957-theralase-tlc-2000-laser-system-recall-laser-power-may-be · Updated September 23, 2026 · FDA enforcement record: FDA #Z-1354-2020

Cite this page

“Theralase TLC-2000 Laser System Recall: Laser Power May Be Too Low.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/66957-theralase-tlc-2000-laser-system-recall-laser-power-may-be. Based on FDA recall #Z-1354-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1354-2020%22&limit=1).

Theralase Inc. recalled the TLC-2000 Therapeutic Medical Laser System because its 905 nm laser diodes may be below rated power output, according to the FDA on September 26, 2019.

How to tell if you have it

  • Brand: Theralase
  • Product: TLC-2000 Therapeutic Medical Laser System
  • Serial Numbers: 3245 to 3336 inclusive

The hazard

The recall involves 905 nm laser diodes that may be below rated power output.

Context

GovInfoNow's records show Theralase Inc. has five other recalls on record since September 26, 2019. Other recent recalls of similar products include Olympus SOLTIVE Laser System Recall (February 27, 2026), Lutronic DermaV Laser System Recall (August 6, 2026), and Diowave Laser System Recall (January 9, 2026).

How to tell if you have this one

Check the serial number on your TLC-2000 device. Affected units have serial numbers from 3245 to 3336 inclusive.

  • Brand
    Theralase
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Number

    Look for the serial number on your TLC-2000 device to confirm if it falls within 3245 to 3336.

How this recall unfolded

Recall timeline

FDA terminated this recall 8 months after the firm started it.

1. Firm started the recall: Sep 26, 201912. FDA classified it Class III: Feb 24, 202023. Published in FDA’s Enforcement Report: Mar 4, 202034. FDA terminated the recall: Jun 4, 2020420192020
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1354-2020 (September 26, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1354-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA