DSAART LLC: Device Recall
Recall #Z-0945-2026 · 09/26/2025
Recall Details
- Recall Number
- Z-0945-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- DSAART LLC
- Status
- Ongoing
- Date Initiated
- 09/26/2025
- Location
- Carson City, NV, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 118 implants
Reason for Recall
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Product Description
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 Implant style 1 size 3 UDI-DI code: B490501103 501-105 - Gluteal Implant style 1 size 5 UDI-DI code: B490501105 501-206 - Gluteal Implant style 2 size 6 UDI-DI code: B490501206 501-301 - Gluteal Implant style 3 size 1 UDI-DI code: B490501301 501-302 - Gluteal Implant style 3 size 2 UDI-DI code: B490501302 501-303 - Gluteal Implant style 3 size 3 UDI-DI code: B490501303 501-304 - Gluteal Implant style 3 size 4 UDI-DI code: B490501304 501-305 - Gluteal Implant style 3 size 5 UDI-DI code: B490501305 501-306 - Gluteal Implant style 3 size 6 UDI-DI code: B490501306 501-307 - Gluteal Implant style 3 size 7 UDI-DI code: B490501307 501-309 - Gluteal Implant style 3 size 9 UDI-DI code: B490501309 501-310 - Gluteal Implant style 3 size 10 UDI-DI code: B490501310
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
Other Recalls by DSAART LLC
- Class II: Risk 09/26/2025
- Class II: Risk 09/26/2025
- Class II: Risk 09/26/2025
- Class II: Risk 09/26/2025
- Class II: Risk 09/26/2025