Reported Dec 24, 2025 · Ongoing
Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1…
Dsaart LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DSAART LLC · 2950 Arrowhead Dr · Carson City, NV · 89706-0488
Is this the product you have?
- Brand NameAART
- Gluteal Implant Product NameGluteal
- Implant Model/Catalog Numbers501-101 - Gluteal
- Implant style 1 size 1 UDI-DI codeB490501101 501-103 - Gluteal
- Implant style 1 size 3 UDI-DI codeB490501103 501-101
- UDI-DI codeB490501101 501-103 - Gluteal
- Implant style 1 size 3 UDI-DI codeB490501103 501-105 - Gluteal
- Implant style 1 size 5 UDI-DI codeB490501105 501-206 - Gluteal
- Implant style 2 size 6 UDI-DI codeB490501206 501-301 - Gluteal
- Implant style 3 size 1 UDI-DI codeB490501301 501-302 - Gluteal
- Implant style 3 size 2 UDI-DI codeB490501302 501-303 - Gluteal
- Implant style 3 size 3 UDI-DI codeB490501303 501-304 - Gluteal
- Implant style 3 size 4 UDI-DI codeB490501304 501-305 - Gluteal
- Implant style 3 size 5 UDI-DI codeB490501305 501-306 - Gluteal
- Implant style 3 size 6 UDI-DI codeB490501306 501-307 - Gluteal
- Implant style 3 size 7 UDI-DI codeB490501307 501-309 - Gluteal
- Implant style 3 size 9 UDI-DI codeB490501309 501-310 - Gluteal
- Implant style 3 size 10 UDI-DI codeB490501310
- Lot codes and dates
13 of 13 products
Products covered by this recall Model / number Product as published 501-103Lot Number: 24-01-030 Model/ UDI-DI code: B490501103 501-105Lot Numbers: 24-12-003 25-06-014 25-07-022 Model/ UDI-DI code: B490501105 501-206Lot Numbers: 24-07-012 24-09-013 Model/ UDI-DI code: B490501206 501-301Lot Number: 24-06-017 Model/ UDI-DI code: B490501301 501-302Lot Numbers: 23-10-020 25-01-021 Model/ UDI-DI code: B490501302 501-303Lot Numbers: 24-12-001 25-01-016 25-03-003 Model/ UDI-DI code: B490501303 501-304Lot Numbers: 24-10-004 24-11-001 25-01-017 25-02-011 25-03-003 25-04-009 Model/ UDI-DI code: B490501304 501-305Lot Numbers: 24-01-005 24-10-005 24-02-018 24-12-016 Model/ UDI-DI code: B490501305 501-306Lot Numbers: 24-09-009 25-01-001 25-03-004 25-04-010 Model/ UDI-DI code: B490501306 501-307Lot Numbers: 24-10-011 25-01-002 25-06-027 Model/ UDI-DI code: B490501307 501-309Lot Numbers: 24-09-010 24-12-002 25-04-007 Model/ UDI-DI code: B490501309 501-310Lot Number: 24-02-022 Model/ UDI-DI code: B490501310 — Lot Numbers: 24-10-010 25-02-009 - Amount recalled
- 118 implants
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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