Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Soltive SuperPulsed Laser System Wireless Footswitch Recalled by Olympus Corporation of the Americas Due to Difficulties in pairing the wireless footswitch with the...

Date: May 31, 2024
Company: Olympus Corporation of the Americas
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Olympus Corporation of the Americas directly.

Affected Products

Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL

Quantity: 1,838 Units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Olympus Corporation of the Americas

Olympus Corporation of the Americas has 378 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report