Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI-DI code: B4904012026
FDA Recall Z-0947-2026 · Posted 2025-12-18
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Recalling FirmDSAART LLC
Recall StatusOpen, Classified
Product CodeLZK
Date Initiated2025-09-26
Product Quantity2 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.
Firm 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 **.
Root Cause
No Marketing Application
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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