FDA-Device2025-12-24Class IIMISBRANDING
AART Malar Implant recalled for lack of FDA approval and specification deviations
Stop using AART Malar Implants
DSAART LLC distributed AART Malar Implants (model 401-202-5 and 401-202-6, lot numbers 24-01-014 and 24-01-015) without obtaining required FDA premarket approval and with deviations from established manufacturing specifications. Two implants were affected and distributed across multiple U.S. states.
- If you received one of these implants, contact your surgeon or healthcare provider immediately.
- Do not use this product.
- Report any complications or injuries to the FDA MedWatch program at 1-888-SAFEFDA or online at fda.gov/medwatch.
Hazard
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Sold states
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
Affected count
2 implants
Manufactured in
2950 Arrowhead Dr, Carson City, NV, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0947-2026Don't want to check this manually?
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