CLARITY II Laser System — Class II medical device recall Z-1558-2026
Ongoing recall by Lutronic Corporation, reported 2026-03-18, distributed nationwide. Reports of devices sparking/popping and potentially burning patients.
| Recall number | Z-1558-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lutronic Corporation, Goyang, N/A, Korea (the Republic of) |
| Recall initiated | 2026-01-27 |
| Classified | 2026-03-12 |
| Reported by FDA | 2026-03-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, HK, JP, KR, PH, SG, TH, TW, VN |
| Quantity | 1,525 units |
| UPC / GTIN / UDI-DI | 08809447653723 |
| Serial numbers | C2014K002, C3019H002, C3019H008, C3019J007, C3019J008, C3019J009, C3019J010, C3019J014, C3019J015, C3019J016, C3019J017, C3019J018, C3019K001, C3019K003, C3019K004, C3019K005, C3019K007, C3019K008, C3019K009, C3019K010, C3019L001, C3019L002, C3019L003, C3019L004, C3019L005 and 475 more |
| Model numbers | 1110200210 |
Product
CLARITY II Laser System; Model No. 1110200210.
Reason for recall
Reports of devices sparking/popping and potentially burning patients.
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-1558-2026. 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.