Class II — DSAART LLC
| Recalling firm | DSAART, LLC |
|---|---|
| Registered facility | DSAART, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances. |
| Product | Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 600-602 - Silicone Carving Implant Style 6 Size 2 UDI-DI code: B490600602 600-601-9 - Silicone Carving Implant Style 6 Size 1 with Suture Tabs UDI-DI code: B4906006019 600-603-9 - Silicone Carving Implant Style 6 Size 3 with Suture Tabs UDI-DI code: B4906006039 600-604-9 - Silicone Carving Implant Style 6 Size 4 with Suture Tabs UDI-DI code: B4906006049 600-602-3-9 - Silicone Carving Implant Style 6 Size 2 Smooth … |
| Quantity | 369 implants |
| 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 |
| Initiated | 2025-09-26 |
| Classified | 2025-12-18 |
| Recall number | Z-0944-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DSAART LLC (Z-0944-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97704/
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