[pending] Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbe
Pending LLM rewrite. Source: FDA_DEVICE Z-0944-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
The recalled product
- 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 Carvi
- Manufacturer
- DSAART LLC
- Category
- Medical Device — Devices
Distribution
Distributed in 27 states:
- AR
- AZ
- CA
- CO
- CT
- DC
- FL
- GA
- IL
- KY
- MA
- MD
- MI
- MN
- MS
- NE
- NJ
- NY
- OH
- OK
- PA
- PR
- TX
- UT
- VA
- WA
- WI
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