Silicone carving implants recalled over specification deviations and missing clearance
DSAART is recalling 369 AART Silicone Carving Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites a specification deviation and a premarket clearance shortfall with no stated consequence or reported harm.
Plain-English summary
AART Silicone Carving Implants from DSAART LLC are being recalled, covering catalog numbers including 600-601 and 600-602 with their corresponding UDI-DI codes.
The recall follows manufactured products that deviated from established specifications and were distributed without obtaining the required FDA premarket approvals or clearances.
The record lists 369 implants, with catalog and lot details recorded in the enforcement record. Distribution covered Arkansas, Arizona, California, Colorado, Connecticut, the District of Columbia, Florida, Georgia, Kentucky, Illinois, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas, Utah, Virginia and Washington. The FDA has classified the action as Class II.
The record cites a specification deviation and a clearance shortfall without describing a consequence, and states no injuries. Facilities should follow the firm's instructions.
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…
- Manufacturer
- DSAART LLC
- Affected units
- 369
Distribution
Part of a larger recall action
This product is one of 6 recalled by DSAART LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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