Candela Laser GentleLase Pro Recalled for Unintended Pulse Emission Risk
Candela Corporation is recalling 1,258 GentleLase Pro laser surgical instruments because they may emit an unintended single pulse before the trigger is pressed, posing an injury risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall involving a powered surgical instrument that may cause injury due to unintended pulse emission, meeting the criteria for a Severe rating.
Plain-English summary
Candela Corporation is recalling 1,258 units of the Candela Laser GentleLase Pro and GentleLase Pro LE powered laser surgical instruments. These devices are used for dermatological purposes. The recall covers specific model numbers 9914-00-9015 and 9914-00-9040, with serial numbers ranging from 9914-9015-0005 through 9914-9015-1259 and 9914-9040-0716 through 9914-9040-1214.
The recall is being issued because an unintended single pulse may be emitted to the handpiece prior to the pressing of the trigger or footswitch. This malfunction could cause injury to the patient or operator. The agency has classified this as a Class II recall.
The affected units were distributed worldwide, including nationwide in the United States and internationally to countries such as Azerbaijan, Bulgaria, Chile, and others, as well as to subsidiaries in Australia, France, Germany, and other locations. Users should contact Candela Corporation for instructions on how to address the defect.
The recalled product
- 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
- Manufacturer
- Candela Corporation
- Hazard
- Affected units
- 1,258
Distribution
Distributed nationwide across the United States.
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