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RecallWatchMedical Device Safety
Class IIOngoingZ-0945-2026

DSAART LLC recalls Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers:…

DSAART LLCCarson City, NV, United StatesReported Dec 24, 2025 · 6 months ago
Legal News Analyst ·

Reason for recall

Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI-DI codeCatalog # Number
    59 affected lots
    24-01-030501-103B49050110324-12-00325-06-01425-07-022501-105B490501105
    +51 more24-07-01224-09-013501-206B49050120624-06-017501-301B49050130123-10-02025-01-021501-302B49050130224-12-00125-01-01625-03-003501-303B49050130324-10-00424-11-00125-01-01725-02-01125-03-00325-04-009501-304B49050130424-01-00524-10-00524-02-01824-12-016501-305B49050130524-09-00925-01-00125-03-00425-04-010501-306B49050130624-10-01125-01-00225-06-027501-307B49050130724-09-01024-12-00225-04-007501-309B49050130924-02-022501-310B49050131024-10-01025-02-009

What the firm is doing

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 **.

DistributionShow details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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