Recall Z-0945-2026 ยท MIB Elastomer, Silicone Block
DSAART LLC
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
| Date | Dec 18, 2025 (initiated Sep 26, 2025) |
| Status | Open, Classified |
| Reason | Manufactured products deviated from established specifications and were distributed without obtaining the required FDA premarket approvals or clearances. |
| Root cause | No Marketing Application |
| Action | 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 produc |
| Quantity | 118 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, TX, UT, VA, WA, WI and Puerto Rico. O.U.S.: N/A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021839 | AART GLUTEAL IMPLANT Aesthetic and Reconstructive Technologies, Inc., Jul 16, 2002 |