BEUDAMED
    FDA Recall Open, Classified

    Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-DI code: B4905001065 500-106-6 Pectoral Implant style 1 size 6 right UDI-DI code: B4905001066 500-200-5 Pectoral Implant style 2 size 0 left UDI-DI code: B4950020205 500-200-6 500-201-5 500-201-6 500-202-5 500-202-6 500-403-5 500-403-6

    Recall: Z-0948-2026 · Initiated September 26, 2025

    Recall

    Recall Number
    Z-0948-2026
    Event Number
    97704
    Firm
    DSAART LLC
    FEI Number
    3003897287
    Product Code
    MIC
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    September 26, 2025
    Posted
    December 18, 2025
    Address
    2950 Arrowhead Dr, Carson City, NV, 89706-0488

    Description

    Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-DI code: B4905001065 500-106-6 Pectoral Implant style 1 size 6 right UDI-DI code: B4905001066 500-200-5 Pectoral Implant style 2 size 0 left UDI-DI code: B4950020205 500-200-6 500-201-5 500-201-6 500-202-5 500-202-6 500-403-5 500-403-6

    Reason

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

    Action

    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 **.

    Distribution

    U.S.: AR, AZ, CA, CO, CT, DC, FL, GA, KY, IL, MA, MD, MI, MN, MS, NE, NJ, NY, OH, OK, PA, PR, TX, UT, VA, WA, and WI O.U.S.: N/A

    Quantity

    41 implants