TLC-2000 Therapeutic Medical Laser System — Class III medical device recall Z-0607-2020
Terminated recall by Theralase Inc., reported 2019-12-11, distributed nationwide. Device was shipped without a Unique Device Identification (UDI) label and a separate label identifies the powe
| Recall number | Z-0607-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Theralase Inc., East York, Canada |
| Recall initiated | 2019-09-26 |
| Classified | 2020-02-18 |
| Reported by FDA | 2019-12-11 |
| Terminated | 2020-12-03 |
| Distributed | Nationwide (US) |
| Quantity | 306 units |
| Reason classes | labeling |
| Serial numbers | 3204, TLC-2002 |
Product
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
Reason for recall
Device was shipped without a Unique Device Identification (UDI) label and a separate label identifies the power pack as CE Marked when the device has not yet received the CE Mark.
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-0607-2020. 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.