Recall Z-0944-2026 ยท MIB Elastomer, Silicone Block
DSAART LLC
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
| 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 | 369 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
| K021820 | AART SILICONE CARVING BLOCK Aesthetic and Reconstructive Technologies, Inc., Jul 16, 2002 |