Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Recalled by DSAART LLC Due to Due to manufactured products that deviated from established...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact DSAART LLC directly.
Affected Products
Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-DI code: B4905001065 500-106-6 Pectoral Implant style 1 size 6 right UDI-DI code: B4905001066 500-200-5 Pectoral Implant style 2 size 0 left UDI-DI code: B4950020205 500-200-6 500-201-5 500-201-6 500-202-5 500-202-6 500-403-5 500-403-6
Quantity: 41 implants
Why Was This Recalled?
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Where Was This Sold?
This product was distributed to 26 states: AZ, AR, CA, CO, CT, FL, GA, IL, KY, MD, MA, MI, MN, MS, NE, NJ, NY, OH, OK, PA, TX, UT, VA, WA, WI, DC
About DSAART LLC
DSAART LLC has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report