Reported Dec 24, 2025 · Ongoing
Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2…
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
- Malar Implant Product NameMalar
- Implant Model/Catalog Number401-202-5 Malar
- Implant style 2 size 2 left UDI-DI codeB4904012025 401-202-6 Malar Implant
- style 2 size 2 right UDI-DI codeB4904012026
- Lot codes and dates
- Malar Implant Model/Catalog Number401-202-5
- UDI-DI codeB4904012025
- Lot Number24-01-014
- Model/Catalog Number401-202-6
- UDI-DI codeB4904012026
- Lot Number24-01-015
- Amount recalled
- 2 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.
Want the full recall guide?
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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