Olympus Corporation of the Americas: Medical Device Recall in 2024 - (Recall #: Z-1384-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

SOLTIVE Pro SuperPulsed Laser (TFL-SLS )

Product Classification:

Class II

Date Initiated: January 29, 2024

Date Posted: April 3, 2024

Recall Number: Z-1384-2024

Event ID: 94125

Reason for Recall:

A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.

Status: Ongoing

Product Quantity: 17 Units (OUS Only)

Code Information:

Model Number: TFL-SLS; UDI/DI: 00821925044135; All serial numbers.

Distribution Pattern:

Domestic: OUS Only; International distribution in the states of Australia, Chile, Germany, Hong Kong, Japan, New Zealand and Singapore.

Voluntary or Mandated:

Voluntary: Firm initiated