Olympus Corporation of the Americas: Medical Device Recall in 2024 - (Recall #: Z-1385-2024)

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 Premium SuperPulsed Laser (TFL-PLS )

Product Classification:

Class II

Date Initiated: January 29, 2024

Date Posted: April 3, 2024

Recall Number: Z-1385-2024

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: 203 Units (OUS Only)

Code Information:

Model Number: TFL-PLS; UDI/DI: 00821925044111; 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