Home / Recalls / DSAART LLC / Z-0947-2026

Z-0947-2026 Class II Ongoing

Recalled by DSAART LLC — Carson City, NV

Recall Details

Product Type
Devices
Report Date
December 24, 2025
Initiation Date
September 26, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 implants

Product Description

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

Reason for Recall

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

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

Code Information

Malar Implant Model/Catalog Number: 401-202-5 UDI-DI code: B4904012025 Lot Number: 24-01-014 Model/Catalog Number: 401-202-6 UDI-DI code: B4904012026 Lot Number: 24-01-015

Other recalls by DSAART LLC

  • Z-0946-2026 Class II — Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers (September 26, 2025)
  • Z-0948-2026 Class II — Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog (September 26, 2025)
  • Z-0949-2026 Class II — Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: (September 26, 2025)
  • Z-0945-2026 Class II — Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog N (September 26, 2025)
  • Z-0944-2026 Class II — Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant (September 26, 2025)