# FDA recall Z-0944-2026

> **DSAART LLC** · Class II · device recall initiated 2025-09-26.

## 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 with Suture Tabs UDI-DI code: B49060060239  600-603 -Silicone Carving Implant Style 6 Size 3  UDI-DI code: B490600603  600-603-3-9 - Silicone Carving Implant Style 6 Size 3 Smooth with Suture Tabs UDI-DI code: B49060060339  600-604 - Silicone Carving Implant Style 6 Size 4 UDI-DI code: B490600604  600-605 - Silicone Carving Implant Style 6 Size 5 UDI-DI code: B490600605  600-801 - Silicone Carving

## 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

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

## Key facts

- **Recall number:** Z-0944-2026
- **Recalling firm:** DSAART LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-26
- **Report date:** 2025-12-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carson City, NV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0944-2026

## Citation

> AI Analytics. FDA recall Z-0944-2026. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0944-2026. Source: US FDA. Licensed CC0.

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