AART Silicone Carving Implant (DSAART) – specification deviation (2025)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 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
Brand
DSAART LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
DSAART LLC is recalling Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbe due to Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approval. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Recommended Action
Per FDA guidance
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 **.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, AR, CA, CO, CT, FL, GA, IL, KY, MD, MA, MI, MN, MS, NE, NJ, NY, OH, OK, PA, TX, UT, VA, WA, WI, DC, PR
Page updated: Jan 10, 2026