Recall Z-0948-2026 ยท MIC Implant, Muscle, Pectoralis
DSAART LLC
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
| 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 | 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, 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
| K021337 | AART PECTORALIS IMPLANT Aesthetic and Reconstructive Technologies, Inc., Jul 3, 2002 |