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 Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and IEC-62133 (2nd Edition) standards; however, not tested to IEC-60601-1-2 (3rd edition) standards |
| Product | TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002 |
| Quantity | 202 units |
| Distribution | U.S.A.; Australia, Bahrain, Canada, Hong Kong Province of China, Jordan, Mexico, Pakistan, Philippines, Thailand, Romania |
| Initiated | 2019-09-26 |
| Classified | 2020-02-24 |
| Terminated | 2020-12-03 |
| Recall number | Z-1348-2020 |
| 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-1348-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84842/
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