DSAART LLC recalls Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401…

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

On 09/26/2025, the firm emailed a notice to an affected customer informing them that due to identified testing issues, the firm was requesting return of gluteal implants. On 11/17/2025, the firm send an "URGENT Medical Device removal of AART Silicone Implants" Letter to customer informing them that Alpha Aesthetics is voluntarily removing products as they conduct an analysis to determine the regulatory status of the devices. Customers are instructed to: 1. Either return the affected products that have not been implanted to Alpha Aesthetics at the company's expense, or discard affected products. 2. Acknowledge their actions via the enclosed "Medical Device Return Response" letter/form. For questions or further assistance with this removal, contact ** or email **.

• FDA enforcement recordOfficial FDA database entry for Z-0947-2026
• FDA 510(k) clearance · K021419The device's official FDA premarket clearance record
• FDA device classification · LZKOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.3550The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find DSAART LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.