Elite XPL — Class II medical device recall Z-0169-2015
Terminated recall by Cynosure, Inc., reported 2014-11-12, distributed nationwide. If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light handpiece, the
| Recall number | Z-0169-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cynosure, Inc., Westford, MA, United States |
| Recall initiated | 2014-10-09 |
| Classified | 2014-11-04 |
| Reported by FDA | 2014-11-12 |
| Terminated | 2015-03-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DE, FR, GB, IT, NL, UA |
| Quantity | 322 units |
Product
Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System
Reason for recall
If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light handpiece, there is a potential risk of an electrical shock
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-0169-2015. 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.