BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 600-602 - Silicone Carving Implant Style 6 Size 2 UDI-DI code: B490600602 600-601-9 - Silicone Carving Implant Style 6 Size 1 with Suture Tabs UDI-DI code: B4906006019 600-603-9 - Silicone Carving Implant Style 6 Size 3 with Suture Tabs UDI-DI code: B4906006039 600-604-9 - Silicone Carving Implant Style 6 Size 4 with Suture Tabs UDI-DI code: B4906006049 600-602-3-9 - Silicone Carving Implant Style 6 Size 2 Smooth with Suture Tabs UDI-DI code: B49060060239 600-603 -Silicone Carving Implant Style 6 Size 3 UDI-DI code: B490600603 600-603-3-9 - Silicone Carving Implant Style 6 Size 3 Smooth with Suture Tabs UDI-DI code: B49060060339 600-604 - Silicone Carving Implant Style 6 Size 4 UDI-DI code: B490600604 600-605 - Silicone Carving Implant Style 6 Size 5 UDI-DI code: B490600605 600-801 - Silicone Carving Implant Style 8 Size 1 UDI-DI code: B490600801 600-803 - Silicone Carving Implant Style 8 Size 3 UDI-DI code: B490600803 600-804 - Silicone Carving Implant Style 8 Size 4 UDI-DI code: B490600804 Intended for Augmentation and reconstructive surgery. * Pending information

    Recall: Z-0944-2026 · Reported December 24, 2025

    Enforcement

    Recall Number
    Z-0944-2026
    Event ID
    97704
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DSAART LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 24, 2025
    Initiation Date
    September 26, 2025
    Classification Date
    December 18, 2025
    Address
    2950 Arrowhead Dr, Carson City, NV, 89706-0488, United States

    Description

    Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 600-602 - Silicone Carving Implant Style 6 Size 2 UDI-DI code: B490600602 600-601-9 - Silicone Carving Implant Style 6 Size 1 with Suture Tabs UDI-DI code: B4906006019 600-603-9 - Silicone Carving Implant Style 6 Size 3 with Suture Tabs UDI-DI code: B4906006039 600-604-9 - Silicone Carving Implant Style 6 Size 4 with Suture Tabs UDI-DI code: B4906006049 600-602-3-9 - Silicone Carving Implant Style 6 Size 2 Smooth with Suture Tabs UDI-DI code: B49060060239 600-603 -Silicone Carving Implant Style 6 Size 3 UDI-DI code: B490600603 600-603-3-9 - Silicone Carving Implant Style 6 Size 3 Smooth with Suture Tabs UDI-DI code: B49060060339 600-604 - Silicone Carving Implant Style 6 Size 4 UDI-DI code: B490600604 600-605 - Silicone Carving Implant Style 6 Size 5 UDI-DI code: B490600605 600-801 - Silicone Carving Implant Style 8 Size 1 UDI-DI code: B490600801 600-803 - Silicone Carving Implant Style 8 Size 3 UDI-DI code: B490600803 600-804 - Silicone Carving Implant Style 8 Size 4 UDI-DI code: B490600804 Intended for Augmentation and reconstructive surgery. * Pending information

    Reason

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

    Code Info

    AART Silicone Carving Implant Model/Catalog Number: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 Lot Numbers: 25-01-003 25-01-010 25-01-022 25-02-012 25-03-001 25-04-004 25-05-006 25-05-015 25-06-011 25-06-017 Model/Catalog Number: 600-602 UDI-DI code: B490600602 Lot Numbers: 25-02-006 25-02-021 25-03-007 25-04-005 25-05-017 25-06-015 Model/Catalog Number: 600-601-9 UDI-DI code: B4906006019 Lot Number: 25-02-017 Model/Catalog Number: 600-603-9 UDI-DI code: B4906006039 Lot Number: 25-02-026 Model/Catalog Number: 600-604-9 UDI-DI code: B4906006049 Lot Number: 25-02-018 Model/Catalog Number: 600-602-3-9 UDI-DI code: B49060060239 Lot Number: 24-04-011 Model/Catalog Number: 600-603 UDI-DI code: B490600603 Lot Numbers: 24-11-005 25-01-011 25-02-007 25-02-020 Model/Catalog Number: 600-603-3-9 UDI-DI code: B49060060339 Lot Number: 24-01-013 Model/Catalog Number: 600-604 UDI-DI code: B490600604 Lot Numbers: 24-10-013 25-01-012 25-02-024 25-04-012 Model/Catalog Number: 600-605 UDI-DI code: B490600605 Lot Numbers: 24-05-003 25-01-013 25-06-012 Model/Catalog Number: 600-801 UDI-DI code: B490600801 Lot Numbers: 24-11-017 25-01-004 25-01-014 25-01-023 25-07-009 Model/Catalog Number: 600-803 UDI-DI code: B490600803 Lot Numbers: 24-09-016 25-01-015 Model/Catalog Number: 600-804 UDI-DI code: B490600804 Lot Number: 23-10-005

    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

    369 implants