TLC-2000 Therapeutic Medical Laser System — Class III medical device recall Z-1353-2020
Terminated recall by Theralase Inc., reported 2020-03-04. 660 nm laser diodes may be below rated power output.
| Recall number | Z-1353-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Theralase Inc., East York, N/A, Canada |
| Recall initiated | 2019-09-26 |
| Classified | 2020-02-24 |
| Reported by FDA | 2020-03-04 |
| Terminated | 2020-12-03 |
| Countries outside the US | AU, BH, CA, CN, HK, JO, MX, PH, PK, RO, TH |
| Quantity | 92 units |
| Serial numbers | 3245, 3336 |
Product
TLC-2000 Therapeutic Medical Laser System
Reason for recall
660 nm laser diodes may be below rated power output.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1353-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.