DSAART LLC: Device Recall

Recall Details

Recall Number

Z-0944-2026

Classification

Class II

Product Type

Device

Recalling Firm

DSAART LLC

Status

Ongoing

Date Initiated

09/26/2025

Location

Carson City, NV, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

369 implants

Reason for Recall

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

Product 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

Distribution Pattern

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

Other Recalls by DSAART LLC

• Class II: Risk 09/26/2025
  Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
• Class II: Risk 09/26/2025
  Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
• Class II: Risk 09/26/2025
  Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
• Class II: Risk 09/26/2025
  Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
• Class II: Risk 09/26/2025
  Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

View all recalls by DSAART LLC →