Olympus Corporation of the Americas: Medical Device Recall in 2024 - (Recall #: Z-2504-2024)

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 System, Model TFL-PLS

Product Classification:

Class II

Date Initiated: May 31, 2024

Date Posted: August 14, 2024

Recall Number: Z-2504-2024

Event ID: 94964

Reason for Recall:

Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.

Status: Ongoing

Product Quantity: 1,585 Units

Code Information:

Model: TFL-PLS; UDI-DI: 00821925044111; Serial Numbers: All Serial Numbers.

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.

Voluntary or Mandated:

Voluntary: Firm initiated