IDS LTD: Medical Device Recall in 2025 - (Recall #: Z-0804-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Smaxel Fractional CO2 Laser, a Class IV medical laser system.

Product Classification:

Class II

Date Initiated: October 16, 2024

Date Posted: January 15, 2025

Recall Number: Z-0804-2025

Event ID: 96034

Reason for Recall:

The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.

Status: Ongoing

Product Quantity: 23

Code Information:

unknown

Distribution Pattern:

Worldwide - US Nationwide Distribution

Voluntary or Mandated:

FDA Mandated