Class III — Theralase Inc.
| Recalling firm | THERALASE INC. |
|---|---|
| Registered facility | Theralase Technologies Inc. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC, 3.75 A, 90 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 4th edition specification) shipped versus Power supply (Model Number: TLC-2003) MENB1100A2403F01 (24 VDC, 4.2 A, 101 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 3rd edition specification) |
| Product | TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain. |
| Quantity | 76 units |
| Distribution | Worldwide distribution - US Nationwide and countries Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania. |
| Initiated | 2019-09-26 |
| Classified | 2020-02-19 |
| Terminated | 2020-12-03 |
| Recall number | Z-1326-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Theralase Inc. (Z-1326-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84845/
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