CLASS III Device recall · Reported 4 Mar 2020 · FDA Enforcement Report

TLC-2000 Therapeutic Medical Laser System recalled by Theralase

Theralase is recalling TLC-2000 Therapeutic Medical Laser System. The recall was initiated on 26 Sep 2019 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesSerial Numbers: 3245 to 3336 inclusive

Quantity recalled92 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1354-2020
FDA event ID: 84843
Recalling firm: Theralase, East York, N/A
Classification: Class III
Status: Terminated
Recall initiated: 26 Sep 2019
FDA classified: 24 Feb 2020
Reported: 4 Mar 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

26 Sep 2019	Recall initiated by company
24 Feb 2020	Classified by FDA	+151 days
4 Mar 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

905 nm laser diodes may be below rated power output.

Product as listed by the FDA

TLC-2000 Therapeutic Medical Laser System

Where it was distributed

USA; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania

Questions about this recall

Why was it recalled?

905 nm laser diodes may be below rated power output.

Which lots are affected?

Serial Numbers: 3245 to 3336 inclusive

Where was it sold?

USA; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Theralase

All 7

Reported	Class	Recall	Company	Reason	Where
4 Mar 2020Device	CLASS III	TLC-2000 Therapeutic Medical Laser System recalled by Theralase	Theralase	Other	N/A
4 Mar 2020Device	CLASS III	TLC-2000 Therapeutic Medical Laser System Power Pack recalled	Theralase	Device Malfunction	N/A
26 Feb 2020Device	CLASS III	TLC-2000 Therapeutic Medical Laser System recalled by Theralase	Theralase	Other
26 Feb 2020Device	CLASS III	TLC-2000 Therapeutic Medical Laser System recalled by Theralase	Theralase	Other	Nationwide
11 Dec 2019Device	CLASS III	Tlc-2000 Therapeutic Medical Laser System recalled by Theralase	Theralase	Other	Nationwide

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