Class II — Potential Health Hazard

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

Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Recalled by DSAART LLC Due to Due to manufactured products that deviated from established...

Date: September 26, 2025
Company: DSAART LLC
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 DSAART LLC directly.

Affected Products

Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI-DI code: B4904012026

Quantity: 2 implants

Why Was This Recalled?

Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

Where Was This Sold?

This product was distributed to 26 states: AZ, AR, CA, CO, CT, FL, GA, IL, KY, MD, MA, MI, MN, MS, NE, NJ, NY, OH, OK, PA, TX, UT, VA, WA, WI, DC

Affected (26 states)Not affected

About DSAART LLC

DSAART LLC has 6 total recalls tracked by RecallDetector.

Related Recalls

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