DSAART LLC
FDA Regulatory Profile
DSAART LLC has 6 FDA recalls, 5 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- Z-0947-2026 · Class II · Sep 26, 2025
- Latest inspection
- Oct 14, 2022 · OAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 6 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 5 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0947-2026 | Class II | Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar… | Sep 26, 2025 |
| Z-0948-2026 | Class II | Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5… | Sep 26, 2025 |
| Z-0946-2026 | Class II | Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin… | Sep 26, 2025 |
| Z-0945-2026 | Class II | Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101… | Sep 26, 2025 |
| Z-0949-2026 | Class II | Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf… | Sep 26, 2025 |
| Z-0944-2026 | Class II | Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog… | Sep 26, 2025 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Oct 14, 2022 | Carson City, NV | Devices | Official Action Indicated (OAI) | 3003897287 |
| Aug 5, 2021 | Carson City, NV | Devices | Official Action Indicated (OAI) | 3003897287 |
| May 15, 2019 | Carson City, NV | Devices | Voluntary Action Indicated (VAI) | 3003897287 |
| Mar 25, 2015 | Carson City, NV | Devices | Voluntary Action Indicated (VAI) | 3003897287 |
| Oct 17, 2012 | Carson City, NV | Devices | Voluntary Action Indicated (VAI) | 3003897287 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3003897287 | Carson City, NV | 5 | Oct 14, 2022 |