The Recall Desk

FDA (Devices) recall action 97704

DSAART LLC recalled 6 products on 2025-12-24

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2025-12-24
Critical
0
Units
594

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–6 of 6

  • ModerateFDA (Devices)··2025-12-24

    Pectoral implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 41 AART Pectoral Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    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 si
    Category
    Distribution
    27 states
  • ModerateFDA (Devices)··2025-12-24

    Malar facial implants recalled over specification deviations and missing clearance

    DSAART is recalling 2 AART Malar Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    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
    Category
    Distribution
    27 states
  • ModerateFDA (Devices)··2025-12-24

    Calf implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 35 AART Calf Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 502-104 - Calf Implant style 1 size 4 UDI-DI code: B490502104 502-105 - Calf Implant style 1 size 5 UDI-DI code: B490502105
    Category
    Distribution
    27 states
  • ModerateFDA (Devices)··2025-12-24

    Silicone carving implants recalled over specification deviations and missing clearance

    DSAART is recalling 369 AART Silicone Carving Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    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 Carvi
    Category
    Distribution
    27 states
  • ModerateFDA (Devices)··2025-12-24

    Gluteal implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 118 AART Gluteal Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1 size 1 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3 UDI-DI code: B490501103 501-101 UDI-DI code: B490501101 501-103 - Gluteal
    Category
    Distribution
    27 states
  • ModerateFDA (Devices)··2025-12-24

    Chin implants recalled over specification deviations and missing premarket clearance

    DSAART is recalling 29 AART Chin Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.

    Product
    Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B490400101 400-0103 Chin Implant style 1 size 3 UDI-DI code: B490400103 400-0104 Chin Implant style 1 size 4 UDI-DI code: B490400104 40
    Category
    Distribution
    27 states