Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin ...
FDA Device Recall #Z-0946-2026 — Class II — September 26, 2025
Recall Summary
| Recall Number | Z-0946-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 26, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | DSAART LLC |
| Location | Carson City, NV |
| Product Type | Devices |
| Quantity | 29 implants |
Product Description
Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B490400101 400-0103 Chin Implant style 1 size 3 UDI-DI code: B490400103 400-0104 Chin Implant style 1 size 4 UDI-DI code: B490400104 400-0201 Chin Implant style 2 size 1 UDI-DI code: B490400201 400-0202 Chin Implant style 2 size 2 UDI-DI code: B490400202 400-0301 Chin Implant style 3 size 1 UDI-DI code: B49044301 400-0302 Chin Implant style 3 size 2 UDI-DI code: B490400302
Reason for Recall
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Distribution Pattern
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
Lot / Code Information
Chin Implant Model/Catalog Number: 400-0101 UDI-DI code: B490400101 Lot Number: 25-01-018 Model/Catalog Number: 400-0103 UDI-DI code:B490400103 Lot Numbers: 23-11-018 25-01-019 Model/Catalog Number: 400-0104 UDI-DI code: B490400104 Lot Number: 24-01-016 Model/Catalog Number: 400-0201 UDI-DI code: B409400201 Lot Number: 24-05-012 Model/Catalog Number: 400-0202 UDI-DI code: B490400202 Lot Number: 25-01-020 Model/Catalog Number: 400-0301 UDI-DI code: B490400301 Lot Numbers: 23-09-024 24-03-036 Model/Catalog Number: 400-0302 UDI-DI code: B490400302 Lot Number: 24-03-037
Other Recalls from DSAART LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0949-2026 | Class II | Brand Name: AART Calf Implant Product Name: Ca... | Sep 26, 2025 |
| Z-0947-2026 | Class II | Brand Name: AART Malar Implant Product Name: M... | Sep 26, 2025 |
| Z-0944-2026 | Class II | Brand Name: AART Silicone Carving Implant Produ... | Sep 26, 2025 |
| Z-0948-2026 | Class II | Brand Name: AART Pectoral Implant Product Name... | Sep 26, 2025 |
| Z-0945-2026 | Class II | Brand Name: AART Gluteal Implant Product Name:... | Sep 26, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.