DABRA RA-308 Excimer Laser — Class II medical device recall Z-0050-2021
Terminated recall by Ra Medical Systems, Inc., reported 2020-10-14, distributed nationwide. Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient inj
| Recall number | Z-0050-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ra Medical Systems, Inc., Carlsbad, CA, United States |
| Recall initiated | 2020-07-24 |
| Classified | 2020-10-02 |
| Reported by FDA | 2020-10-14 |
| Terminated | 2023-08-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Quantity | 54 units |
| Serial numbers | RA00027, RA00039, RA00046, RA00049, RA00050, RA00054, RA00055, RA00056, RA00057, RA00058, RA00063, RA00064, RA00065, RA00067, RA00069, RA00070, RA00073, RA00074, RA00081, RA00082, RA00083, RA00084, RA00085, RA00086, RA00088 and 29 more |
Product
DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.
Reason for recall
Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.
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-0050-2021. 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.