Class II — Potential Health Hazard

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

Accure Laser System Recalled by Accure Acne, Inc Due to Laser system's spot tracking system may become misaligned...

Date: December 6, 2023
Company: Accure Acne, Inc
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 Accure Acne, Inc directly.

Affected Products

Accure Laser System, Model: PFMS00004

Quantity: 22

Why Was This Recalled?

Laser system's spot tracking system may become misaligned resulting in the possible risk of delivery of higher-than-expected laser energy to epidermal tissue, which may cause blistering.

Where Was This Sold?

This product was distributed to 10 states: CA, CO, CT, LA, MA, MN, NJ, NY, OH, TX

Affected (10 states)Not affected

About Accure Acne, Inc

Accure Acne, Inc has 1 total recall tracked by RecallDetector.

Related Recalls

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