DSAART LLC is recalling approximately 594 AART brand surgical implants, including silicone carving, gluteal, chin, malar, pectoral, and calf implants. These medical devices are being recalled because they did not meet established manufacturing specifications and were distributed without the necessary FDA premarket approvals or clearances. The recall affects 594 units distributed across 26 U.S. states and Puerto Rico.
Using implants that deviate from specifications or lack regulatory clearance poses a moderate risk to patients. These defects could lead to device failure, adverse tissue reactions, or the requirement for additional surgical procedures to remove or replace the implants.
Intended for Augmentation and reconstructive surgery.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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