Class 2 Device Recall AART Gluteal Implant

• Date Initiated by Firm: September 26, 2025
• Date Posted: December 18, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0945-2026
• Recall Event ID: 97704
• 510(K)Number: K021839
• Product Classification: Elastomer, silicone block - Product Code MIB
• Product: 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
• Code Information: Gluteal Implant Model/Catalog Number: 501-101 UDI-DI code: B490501101 Lot Number: 24-01-030 Model/Catalog Number: 501-103 UDI-DI code: B490501103 Lot Numbers: 24-12-003 25-06-014 25-07-022 Model/Catalog Number: 501-105 UDI-DI code: B490501105 Lot Numbers: 24-07-012 24-09-013 Model/Catalog Number: 501-206 UDI-DI code: B490501206 Lot Number: 24-06-017 Model/Catalog Number: 501-301 UDI-DI code: B490501301 Lot Numbers: 23-10-020 25-01-021 Model/Catalog Number: 501-302 UDI-DI code: B490501302 Lot Numbers: 24-12-001 25-01-016 25-03-003 Model/Catalog Number: 501-303 UDI-DI code: B490501303 Lot Numbers: 24-10-004 24-11-001 25-01-017 25-02-011 25-03-003 25-04-009 Model/Catalog Number: 501-304 UDI-DI code: B490501304 Lot Numbers: 24-01-005 24-10-005 24-02-018 24-12-016 Model/Catalog Number: 501-305 UDI-DI code: B490501305 Lot Numbers: 24-09-009 25-01-001 25-03-004 25-04-010 Model/Catalog Number: 501-306 UDI-DI code: B490501306 Lot Numbers: 24-10-011 25-01-002 25-06-027 Model/Catalog Number: 501-307 UDI-DI code: B490501307 Lot Numbers: 24-09-010 24-12-002 25-04-007 Model/Catalog Number: 501-309 UDI-DI code: B490501309 Lot Number: 24-02-022 Model/Catalog Number: 501-310 UDI-DI code: B490501310 Lot Numbers: 24-10-010 25-02-009
• Recalling Firm/ Manufacturer: DSAART LLC ; 2950 Arrowhead Dr; Carson City NV 89706-0488
• For Additional Information Contact: Kurt Holm; 775-8536800
• Manufacturer 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: 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 **.
• Quantity in Commerce: 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, PR, TX, UT, VA, WA, and WI O.U.S.: N/A
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MIB