Recall Z-0948-2026
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 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 size 0 left UDI-DI code: B4950020205 500-200-6 500-201-5 500-201-6 500-202-5 500-202-6 500-403-5 500-403-6
Codes / lots: Pectoral Implant Model/Catalog Number: 500-106-5 UDI-DI code: B4905001065 Lot Number: 24-03-002 Model/Catalog Number: 500-106-6 UDI-DI code: B4905001066 Lot Number: 24-03-003 Model/Catalog Number: 500-200-5 UDI-DI code: B4905002005 Lot Numbers: 24-12-004 25-02-002 Model/Catalog Number: 500-200-6 UDI-DI code: B4905002006 Lot Numbers: 24-12-005 25-02-003 Model/Catalog Number: 500-201-5 UDI-DI code: B4905002015 Lot Numbers: 24-11-015 25-02-004 25-05-002 Model/Catalog Number: 500-201-6 UDI-DI code: B4905002016 Lot Numbers: 24-12-017 25-02-005 Model/Catalog Number: 500-202-5 UDI-DI code: B4905002025 Lot Numbers: 24-12-018 25-03-018 Model/Catalog Number: 500-202-6 UDI-DI code: B4905002026 Lot Numbers: 24-09-015 25-03-019 Model/Catalog Number: 500-403-5 UDI-DI code: B4905004035 Lot Number: 25-04-020 Model/Catalog Number: 500-403-6 UDI-DI code: B4905004036 Lot Number: 25-04-021
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-0948-2026
- Initiated
- September 26, 2025
- Posted by FDA
- December 18, 2025
- Product code
- MIC – Implant, Muscle, Pectoralis
- Quantity
- 41 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-0946-2026 Class II | Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101…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-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 |