Candela Corporation: Medical Device Recall in 2013 - (Recall #: Z-0348-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 6, 2013

Date Posted: November 27, 2013

Recall Number: Z-0348-2014

Event ID: 66773

Reason for Recall:

Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.

Status: Terminated

Product Quantity: 1258 units

Code Information:

GL Pro Model 9914-00-9015:: SN 9914-9015-0005 through 9914-9015-1259 GL Pro LE Model 9914-00-9040: SN 9914-9040-0716 through 9914-9040-1214

Distribution Pattern:

Worldwide distribution: US (nationwide) and Internationally to: Azerbaijan, Bulgaria, Chile, Czech Republic, Greece, Israel, Kuwait, Qatar, Saudi Arabia, Serbia, Turkey, and the United Arab Emirates and to Subsidiaries in Australia, France, Germany, Italy, Japan, Portugal, Spain, and the United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated