Recall archive / FDA device enforcement
Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size... — FDA record Z-0947-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 26, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
- Classification
- Class II
- Recalling firm
- DSAART LLC
- Quantity
- 2 implants
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0947-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Malar Implant Model/Catalog Number: 401-202-5 UDI-DI code: B4904012025 Lot Number: 24-01-014 Model/Catalog Number: 401-202-6 UDI-DI code: B4904012026 Lot Number: 24-01-015 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 24, 2025
- Recall initiation date
- Sep 26, 2025
- Center classification date
- Dec 18, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.