Candela Laser GentleLase Pro — Class II medical device recall Z-0348-2014
Terminated recall by Candela Corporation, reported 2013-11-27, distributed nationwide. Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury
| Recall number | Z-0348-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Candela Corporation, Wayland, MA, United States |
| Recall initiated | 2013-11-06 |
| Classified | 2013-11-18 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2015-06-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BG, CL, CZ, DE, ES, FR, GB, GR, IL, IT, JP, KW, PT, QA, RS, SA, TR |
| Quantity | 1,258 units |
| Model numbers | 9914-00-9015, 9914-00-9040, 9914-9015-0005, 9914-9040-0716 |
Product
Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model number: 9914-00-9040
Reason for recall
Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause 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-0348-2014. 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.