Recall Z-0946-2026
Dsaart LLC · initiated September 26, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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 400-0201 Chin Implant style 2 size 1 UDI-DI code: B490400201 400-0202 Chin Implant style 2 size 2 UDI-DI code: B490400202 400-0301 Chin Implant style 3 size 1 UDI-DI code: B49044301 400-0302 Chin Implant style 3 size 2 UDI-DI code: B490400302
Codes / lots: Chin Implant Model/Catalog Number: 400-0101 UDI-DI code: B490400101 Lot Number: 25-01-018 Model/Catalog Number: 400-0103 UDI-DI code:B490400103 Lot Numbers: 23-11-018 25-01-019 Model/Catalog Number: 400-0104 UDI-DI code: B490400104 Lot Number: 24-01-016 Model/Catalog Number: 400-0201 UDI-DI code: B409400201 Lot Number: 24-05-012 Model/Catalog Number: 400-0202 UDI-DI code: B490400202 Lot Number: 25-01-020 Model/Catalog Number: 400-0301 UDI-DI code: B490400301 Lot Numbers: 23-09-024 24-03-036 Model/Catalog Number: 400-0302 UDI-DI code: B490400302 Lot Number: 24-03-037
Reason for recall
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
FDA-determined cause: No Marketing Application
Action taken
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 **.
Details
- Recall number
- Z-0946-2026
- Initiated
- September 26, 2025
- Posted by FDA
- December 18, 2025
- Product code
- FWP – Prosthesis, Chin, Internal
- Quantity
- 29 implants
- 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
- Recalling firm
- Dsaart LLC, Carson City, NV
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0944-2026 Class II | Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant…Due to manufactured products that deviated from established specifications and being distributed without… | 09/26/2025Open, Classified |
| Z-0945-2026 Class II | Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers:…Due to manufactured products that deviated from established specifications and being distributed without… | 09/26/2025Open, Classified |
| Z-0947-2026 Class II | Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number:…Due to manufactured products that deviated from established specifications and being distributed without… | 09/26/2025Open, Classified |
| Z-0948-2026 Class II | Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number:…Due to manufactured products that deviated from established specifications and being distributed without… | 09/26/2025Open, Classified |
| Z-0949-2026 Class II | Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 -…Due to manufactured products that deviated from established specifications and being distributed without… | 09/26/2025Open, Classified |